Hologic, Inc.
Medical device manufacturer in Newark, DE.
118510(k) clearances
18PMA approvals
63recalls
Device types
- KGI Densitometer, Bone 29
- LLZ System, Image Processing, Radiological 13
- HIH Hysteroscope (And Accessories) 13
- IZH System, X-Ray, Mammographic 6
- QDQ Radiological Computer Assisted… 4
- QEP Nucleic Acid Detection System For Non-Viral… 4
- OCC Respiratory Virus Panel Nucleic Acid Assay… 4
- KNW Instrument, Biopsy 4
- QOF Multi-Target Respiratory Specimen Nucleic… 3
- JAQ System, Applicator, Radionuclide… 3
- PQA Vaginitis And Bacterial Vaginosis Nucleic… 3
- KCT Sterilization Wrap Containers, Trays… 3
- PCH Gastrointestinal Pathogen Panel Multiplex… 2
- LSL Dna-Reagents, Neisseria 2
- HIG Insufflator, Hysteroscopic 2
- OOU Parainfluenza Multiplex Nucleic Acid Assay 2
- MUE Full Field Digital, System, X-Ray… 2
- MWP Cabinet, X-Ray System 2
- OMM Test 5, 10-Methylenetetrahydrofolate… 2
- JAA System, X-Ray, Fluoroscopic… 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254090 | I-View®MUE · Traditional | 09/02/2026SE |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special | 08/12/2026SE |
| K253634 | CoolSeal Generator® (CSL-200-90)GEI · Traditional | 06/17/2026SE |
| K251993 | Panther Fusion GI Expanded Bacterial AssayPCH · Traditional | 09/25/2025SE |
| K251868 | Panther Fusion GI Bacterial AssayPCH · Traditional | 09/25/2025SE |
| K243341 | Genius AI Detection 2.0QDQ · Traditional | 07/31/2025SE |
| K243396 | Aptima SARS-CoV-2 AssayQQX · Traditional | 02/13/2025SE |
| K243935 | Aptima CMV Quant AssayPAB · Special | 01/17/2025SE |
| K243345 | Aptima BV Assay; Aptima CV/TV AssayPQA · Special | 11/25/2024SE |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assayQOF · Traditional | 11/15/2024SE |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…HIG · Traditional | 07/25/2024SE |
| K233352 | Aptima HCV Quant Dx AssayMZP · Traditional | 07/24/2024SE |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayQOF · Traditional | 07/18/2024SE |
| K231329 | Aptima Neisseria gonorrhoeae AssayLSL · Traditional | 01/26/2024SE |
| K230451 | Aptima® Chlamydia trachomatis AssayMKZ · Traditional | 11/16/2023SE |
| K231316 | Aptima Trichomonas vaginalis AssayOUY · Traditional | 11/06/2023SE |
| K230096 | Genius AI Detection 2.0 with CC-MLO CorrelationQDQ · Traditional | 05/23/2023SE |
| K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayQOF · Traditional | 05/16/2023SE |
| K231017 | Panther Fusion AdV/hMPV/RV AssayOCC · Special | 05/05/2023SE |
| K221449 | Genius AI Detection 2.0QDQ · Traditional | 10/06/2022SE |
| K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris…QEP · Special | 06/03/2022SE |
| K201019 | Genius AI DetectionQDQ · Traditional | 11/18/2020SE |
| K202294 | Affirm Contrast BiopsyIZH · Special | 10/05/2020SE |
| K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)QEP · Special | 05/17/2020SE |
| K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test…QEP · Special | 03/23/2020SE |
| K191281 | Omni Hysteroscope, Omni Lok cervical sealHIH · Traditional | 08/29/2019SE |
| K190694 | Unifi Workspace v1.0.0LLZ · Traditional | 07/11/2019SE |
| K190515 | Aptima Combo 2 Assay (Panther System)QEP · Traditional | 05/23/2019SE |
| K190452 | Aptima BV AssayPQA · Traditional | 05/23/2019SE |
| K190472 | Aptima CV/TV AssayPQA · Traditional | 05/16/2019SE |
| K182052 | Omni Instrument TrayKCT · Traditional | 02/26/2019SE |
| K182727 | Trident HD Specimen Radiography SystemMWP · Traditional | 01/10/2019SE |
| K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHIH · Special | 12/06/2018SE |
| K181974 | MyoSure XL Tissue Removal Device for FluentHIH · Special | 08/23/2018SE |
| K180825 | Fluent Fluid Management SystemHIG · Traditional | 08/03/2018SE |
| K180681 | Aptima Combo 2 Assay (Panther System)LSL · Traditional | 06/13/2018SE |
| K173901 | MyoSure MANUAL Tissue Removal DeviceHIH · Traditional | 05/08/2018SE |
| K180233 | Eviva Stereotactic Guided Breast Biopsy SystemKNW · Traditional | 04/10/2018SE |
| K172629 | Panther Fusion AdV/hMPV/RV AssayOCC · Traditional | 12/04/2017SE |
| K172282 | Panther Fusion Paraflu AssayOOU · Traditional | 10/23/2017SE |
| K163623 | QuantraLLZ · Traditional | 10/20/2017SE |
| K171963 | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion…OCC · Traditional | 09/26/2017SE |
| K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHIH · Special | 09/20/2017SE |
| K162673 | Aptima Herpes Simplex Viruses 1 & 2 AssayOQO · Traditional | 06/15/2017SE |
| K163052 | Brevera Biopsy System with Corlumina Imaging TechnologyKNW · Traditional | 03/29/2017SE |
| K161575 | Affirm Lateral Arm Upright Biopsy AccessoryIZH · Traditional | 08/10/2016SE |
| K153486 | Affirm Prone Biopsy SystemIZH · Traditional | 04/01/2016SE |
| K153223 | ProParaFlu+ AssayOOU · Special | 12/09/2015SE |
| K153219 | ProFlu+ AssayOCC · Special | 11/20/2015SE |
| K152723 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHIH · Special | 11/13/2015SE |
| K150169 | Sertera Biopsy DeviceKNW · Traditional | 08/14/2015SE |
| K142029 | Myosure Hysteroscopic Tissue Removal SystemHIH · Traditional | 11/26/2014SE |
| K142037 | QuantraLLZ · Traditional | 10/10/2014SE |
| K140960 | Picture Archiving and Communications SystemLLZ · Traditional | 06/13/2014SE |
| K132316 | MultiviewLLZ · Traditional | 10/30/2013SE |
| K131736 | Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack)HIH · Special | 08/22/2013SE |
| K131581 | Myosure Tissue Removal Device (1 Pack and 3 Pack)HIH · Special | 08/22/2013SE |
| K130277 | Single Energy (Se) Femur ExamsKGI · Traditional | 05/31/2013SE |
| K121280 | Myosure Intrument TrayKCT · Traditional | 02/08/2013SE |
| K123873 | Contrast Enhanced Digital MammographyMUE · Traditional | 01/29/2013SE |
| K123530 | Mammography Prior Enhancement (Mpe)LLZ · Traditional | 12/20/2012SE |
| K120947 | THS Instrument TrayKCT · Traditional | 10/17/2012SE |
| K122563 | Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHIH · Special | 09/19/2012SE |
| K122498 | Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack)HIH · Special | 09/10/2012SE |
| K121868 | Myosure Lite Tissue Removal Device (1 Pack), Myosure Lite Tissue Removal Device (3 Pack)HIH · Special | 07/19/2012SE |
| K120472 | QuantraLLZ · Traditional | 06/22/2012SE |
| K120388 | Insight - FD Mini C-Arm Fluoroscopic Imaging SystemOXO · Special | 04/06/2012SE |
| K120593 | Myosure Control UnitHIH · Special | 03/23/2012SE |
| K113356 | Hologic Visceral Fat SoftwareKGI · Traditional | 03/06/2012SE |
| K111508 | Trident Specimen Radiography System, Model : RC TRI-00001MWP · Traditional | 08/19/2011SE |
| K100943 | Invader Factor IINPR · Traditional | 06/02/2011SE |
| K100980 | Invader Factor VNPQ · Traditional | 06/01/2011SE |
| K100987 | Invader Mthfr 677OMM · Traditional | 05/13/2011SE |
| K100496 | Invader Mthfr 1298OMM · Traditional | 04/25/2011SE |
| K103265 | Nhanes Whole Body Dxa Reference DatabaseKGI · Traditional | 03/16/2011SE |
| K103385 | Securview DX Diagnostic WorkstationLLZ · Special | 02/02/2011SE |
| K103512 | Affirm Breast Biopsy Guidance SystemIZH · Special | 01/07/2011SE |
| K102768 | Secrmark Biopsy Site Marking SystemNEU · Special | 12/02/2010SE |
| K100692 | Digital Spot Mammography SystemIZH · Special | 04/06/2010SE |
| K092405 | Mammosite Multi LumenJAQ · Special | 08/27/2009SESU |
| K091378 | Mammosite II Radiation Therapy SystemJAQ · Special | 07/02/2009SESU |
| K091368 | R2 Digitalnow Hd(Digitalnow HD)LLZ · Traditional | 06/04/2009SE |
| K082483 | QuantraLLZ · Traditional | 09/12/2008SE |
| K080711 | 1.10-YEAR Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometer, Model QDR…KGI · Traditional | 09/02/2008SE |
| K081179 | Mammosite Cavity Evaluation DeviceJAQ · Traditional | 05/09/2008SE |
| K072847 | Apex 2.0 Software for QDR X-Ray Bone DensitometersKGI · Traditional | 03/28/2008SE |
| K043617 | Imagechecker CT Cad Software SystemOEB · Traditional | 12/21/2007SE |
| K062107 | Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003LLZ · Special | 08/18/2006SE |
| K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersKGI · Traditional | 07/28/2006SE |
| K060111 | Iva (Mxa II Software Option)KGI · Traditional | 04/24/2006SE |
| K051025 | Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging SystemJAA · Special | 05/13/2005SE |
| K042480 | Infant Whole Body Software Option for QDR DensitometersKGI · Traditional | 10/29/2004SE |
| K041266 | Pediatric Reference DatabaseKGI · Traditional | 08/11/2004SE |
| K041555 | Securview DX Softcopy WorkstationLLZ · Traditional | 08/09/2004SE |
| K040884 | Lorad Digital Spot Mammography SystemIZH · Special | 04/23/2004SE |
| K033224 | Hologic QDR Explorer X-Ray Bone Densitometer, Model ExplorerKGI · Special | 11/05/2003SE |
| K032546 | Hologic DR ImageproLLZ · Traditional | 10/16/2003SE |
| K023398 | Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoveryKGI · Special | 11/08/2002SE |
| K002711 | Hologic QDR X-Ray Bone Densitometer/Models Series 4500, 4000, 2000, 1000 and Hologic…KGI · Traditional | 09/28/2000SE |
| K992775 | Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000…KGI · Traditional | 10/01/1999SE |
| K992677 | Eagle Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000…KGI · Special | 09/03/1999SE |
| K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500…KGI · Traditional | 11/13/1998SE |
| K974058 | FS IV Mini C-Arm SystemJAA · Traditional | 01/12/1998SE |
| K961787 | Body Composition Software Option for QDR X-Ray Bone DensitometersKGI · Traditional | 06/13/1997SE |
| K963363 | Hologic QDR Series X-Ray Boe DensitometersKGI · Traditional | 11/22/1996SE |
| K941362 | Bone Mineral DensitometerKGI · Traditional | 08/30/1995SE |
| K943505 | Hologic QDR-3000 X-Ray Bone DensitometerKGI · Traditional | 01/20/1995SE |
| K926300 | DTX-100KGI · Traditional | 07/23/1993SE |
| K913321 | Hologic QDR-2000 X-Ray Bone DensitometerKGI · Traditional | 11/01/1991SE |
| K913757 | Hologic Cer 20/20, Computed Equal Radio Diag ChestKPR · Traditional | 10/30/1991SE |
| K905753 | QDR-1000 and QDR-1000/W X-Ray Bone DensitometerKGI · Traditional | 06/10/1991SE |
| K905691 | QDR-1000 and with X-Ray Bone DensitometerKGI · Traditional | 05/15/1991SE |
| K894795 | Hologic QDR-1000/W X-Ray Bone DensitometerKGI · Traditional | 08/30/1990SE |
| K890999 | Modified QDR-1000 X-Ray Bone DensitometerKGI · Traditional | 12/21/1989SE |
| K883280 | Hologic QDR-1000 X-Ray Bone Densitometer/ModifiedKGI · Traditional | 09/29/1988SE |
| K883360 | Hologic Model WHF-1 Anthropomorphic Femur PhantomKGI · Traditional | 09/27/1988SE |
| K871446 | Hologic Models BLK-1, DPA/QDR-1 & QCT-1KGI · Traditional | 10/20/1987SE |
| K871553 | X-Caliber Model 1000 Bone Mineral AnalyzerKGI · Traditional | 10/08/1987SE |
PMA approvals
- P210029 Aptima CMV Quant Assay · 05/09/2022 · 2 supplements
- P170025 Aptima HBV Quant Assay · 01/23/2018 · 23 supplements
- P160023 Aptima HCV Quant DX Assay · 02/13/2017 · 18 supplements
- P080003 Selenia Dimensions Full Field Digital Mammography System · 02/11/2011 · 10 supplements
- P070022 Adiana Permanent Contraception System · 07/06/2009 · 22 supplements
- P080015 Cervista HPV 16/18 · 03/12/2009 · 16 supplements
- P080014 Cervista HPV HR and Genfind DNA Extraction Kit · 03/12/2009 · 24 supplements
- P040052 Monoprep Pap Test · 03/03/2006 · 7 supplements
- P030012 Imagechecker CT Cad Software System · 07/08/2004 · 0 supplements
- P020002 Thinprep (R) Imaging System · 06/06/2003 · 9 supplements
- P010025 Lorad Digital Breast Imager · 03/15/2002 · 17 supplements
- P010013 Novasure Impedance Controlled Endometrial Ablation System · 09/28/2001 · 86 supplements
- P010017 Senoscan Full Field Digital Mammography System · 09/25/2001 · 3 supplements
- P970058 M1000 Imagechecker · 06/26/1998 · 26 supplements
- P970032 Salest TM System · 04/29/1998 · 1 supplement
- P970017 Sahara Clinical Bone Sonometer · 03/12/1998 · 1 supplement
- P950039 Thinprep(R) Processor, Model TP 2000 · 05/20/1996 · 36 supplements
- P920048 Fetal Fibronectin Enzyme Immunoassay Kit (Eik) · 09/21/1995 · 26 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2168-2026 Class II | 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB…Complaints have been received of systems developing loose, missing, or broken internal bolts over time. | 04/08/2026Open, Classified |
| Z-2167-2026 Class II | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC…Complaints have been received of systems developing loose, missing, or broken internal bolts over time. | 04/08/2026Open, Classified |
| Z-1949-2026 Class II | Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco…It was identified that certain devices were being operated outside the validated and FDA-cleared display… | 03/23/2026Open, Classified |
| Z-1586-2026 Class II | Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585…Due to product exhibiting potential to generate either invalid or false negative results. | 02/18/2026Open, Classified |
| Z-1314-2026 Class II | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.Presence of particulates in affected devices that can be deposited into breast tissue during use. | 12/15/2025Open, Classified |
| Z-1093-2026 Class II | ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.Fungal contamination of affected lot with Parengyodontium album. | 12/12/2025Open, Classified |
| Z-1170-2025 Class II | Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog…Devices presented a condition in which the inner needle separated from the hub and produced a longer throw… | 01/15/2025Open, Classified |
| Z-1095-2025 Class II | The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN…Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen… | 01/08/2025Open, Classified |
| Z-0907-2025 Class II | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent…Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect… | 12/13/2024Open, Classified |
| Z-0694-2025 Class II | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. | 11/08/2024Open, Classified |
| Z-0328-2025 Class I | BioZorb Marker. Radiographic soft tissue marker.Firm received reports of adverse events/complications that include serious injuries, such as pain… | 10/10/2024Open, Classified |
| Z-3248-2024 Class II | Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions…Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in… | 08/19/2024Open, Classified |
| Z-2373-2024 Class II | Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI…Non-conformance pertains to electromagnetic compatibility requirements according to the international… | 06/13/2024Open, Classified |
| Z-1733-2024 Class I | BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of…Safety Information: Complaints describe complications/adverse events that include pain, infection, rash… | 03/13/2024Open, Classified |
| Z-0782-2024 Class II | PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid…Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. | 12/15/2023Open, Classified |
| Z-1371-2024 Class II | Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001…Use of assay along with plasma specimen may result in error code which would invalidate sample. | 09/14/2023Open, Classified |
| Z-2035-2023 Class II | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from…The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery | 05/02/2023Open, Classified |
| Z-1144-2023 Class II | Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D…C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual | 01/16/2023Open, Classified |
| Z-0669-2025 Class II | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical…IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set | 10/10/2022Completed |
| Z-1858-2022 Class II | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate…Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an… | 08/09/2022Open, Classified |
| Z-0877-2022 Class II | Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro…Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may… | 03/18/2022Open, Classified |
| Z-0750-2022 Class II | Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System…Failed stability specifications for reagent kits that may result in false negative test results. | 01/27/2022Open, Classified |
| Z-1369-2021 Class II | Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product…There is a potential for tube trays to leak which could potentially result in false positive results, false… | 02/26/2021Open, Classified |
| Z-2990-2020 Class II | Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for… | 08/04/2020Terminated |
| Z-1343-2020 Class II | Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions…The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing… | 01/21/2020Terminated |
| Z-2163-2020 Class II | Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S…Reagent component included in flu test kit may cause both high background signal in a true negative sample… | 10/10/2019Open, Classified |
| Z-0685-2019 Class II | I-View Contrast Enhanced Digital Mammography, ASY-08109Calibration issue not possible to visualize contrast uptake in the subtracted mammography images | 12/06/2018Terminated |
| Z-0595-2018 Class II | Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther…The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could… | 01/20/2018Terminated |
| Z-0677-2018 Class II | Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200QRapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products… | 11/29/2017Terminated |
| Z-0676-2018 Class II | Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products… | 11/29/2017Terminated |
| Z-0027-2018 Class II | Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro…An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo… | 09/15/2017Terminated |
| Z-0351-2018 Class II | Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880The firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory… | 07/07/2017Terminated |
| Z-2864-2017 Class II | Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample…A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous… | 06/27/2017Terminated |
| Z-0655-2017 Class II | SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22…Breach in sterile barrier compromising product sterility | 10/28/2016Terminated |
| Z-2869-2016 Class II | Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.Incorrect label on the Sertera Biopsy Kit | 08/22/2016Terminated |
| Z-2766-2016 Class II | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.…Tip Breakage at the glue joint between the obturator body and tip | 08/02/2016Terminated |
| Z-2765-2016 Class II | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.…Tip Breakage at the glue joint between the obturator body and tip | 08/02/2016Terminated |
| Z-2239-2016 Class II | ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to…Cracks ATEC Canister Lids. | 05/31/2016Terminated |
| Z-1580-2016 Class II | Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing… | 03/31/2016Terminated |
| Z-1579-2016 Class II | CF InPlex ASR Card; Catalog Number: 95-0501.Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing… | 03/31/2016Terminated |
| Z-1701-2014 Class II | Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic…Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the… | 05/13/2014Terminated |
| Z-1700-2014 Class II | Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030…Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the… | 05/13/2014Terminated |
| Z-1094-2014 Class II | NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller…NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, | 01/24/2014Terminated |
| Z-2301-2013 Class II | Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The…Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most… | 09/06/2013Terminated |
| Z-1327-2013 Class II | Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a…The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not… | 04/25/2013Terminated |
| Z-1326-2013 Class II | Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini…The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not… | 04/25/2013Terminated |
| Z-2453-2012 Class II | Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The…Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped… | 09/14/2012Terminated |
| Z-2452-2012 Class II | Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The…InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180around vertical axis.… | 09/14/2012Terminated |
| Z-1370-2012 | Hologics SecurView DX workstation, software version 7.3.0 intended for viewing…SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images | 02/28/2012Terminated |
| Z-3015-2011 | Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate The Officemate, FSIII and…The Flex arm connector to C-arm can break and the C-arm that is supported by the flex arm may fall down | 07/21/2011Terminated |
| Z-2285-2010 | Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12…The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20. | 08/11/2010Terminated |
| Z-1160-2010 | ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part…The product is labeled as ATEC0909-12 but it actually contains 0909-20. | 02/01/2010Terminated |
| Z-1728-2009 | Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated…System may not turn off at the end of the x-ray and cause additional x-ray exposure | 04/07/2009Terminated |
| Z-1727-2009 | Hologic QDR 4500 series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated…System may not turn off at the end of the x-ray and cause additional x-ray exposure | 04/07/2009Terminated |
| Z-1726-2009 | Hologic Explorer series Bone Densitometer System Software versions 12.6, 2.3., or 2.4.…System may not turn off at the end of the x-ray and cause additional x-ray exposure | 04/07/2009Terminated |
| Z-1725-2009 | Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or 2.4.…System may not turn off at the end of the x-ray and cause additional x-ray exposure | 04/07/2009Terminated |
| Z-0449-2009 | Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone…Software error may lead to a high estimate of major fracture probability. | 09/24/2008Terminated |
| Z-0275-2009 | ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile…The distal tip of the needle may become detached and remain in the patient, requiring surgical removal. | 09/22/2008Terminated |
| Z-2188-1991 | Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |
| Z-2187-2008 | Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |
| Z-2186-2008 | Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |
| Z-2185-2008 | Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |
| Z-2184-2008 | Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |