Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA product code OXO · Class II (moderate risk) · 21 CFR 892.1650 · Radiology
Fluoroscopy of the human body.
82510(k) clearances
0PMA approvals
49recalls
Manufacturers
- GE OEC Medical Systems, Inc 6
- Siemens Medical Solutions USA, Inc. 6
- Orthoscan, Inc. 5
- Beijing East Whale Imaging Technology Co., Ltd. 5
- Ge Hualun Medical Systems Co. , Ltd. 4
- Philips Medical Systems 4
- Ziehm-Orthoscan, Inc. 3
- Xitec, Inc. 2
- Medirex, Inc. 2
- Ge Dec Medical Systems 2
- Fischer Imaging Corp. 2
- Direx Systems Corp. 2
- Ge Healthcare Surgery GE Oec Medical Systems, Inc. 2
- GE Medical Systems, LLC 2
- Acoma Medical Imaging, Inc. 2
- Breakaway Imaging, LLC 2
- Imt America, Inc. 2
- Allengers Medical Systems Limited 1
- Oec-Diasonics, Inc. 1
- Seemac Reison AB Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253296 | Digital C-ARM with 3DOXO · Traditional | Allengers Medical Systems Limited | 06/05/2026SE |
| K252579 | Orthoscan TAU MVP Mini C-Arm SystemOXO · Traditional | Ziehm-Orthoscan, Inc. | 01/14/2026SE |
| K253269 | OEC One CFDOXO · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 11/26/2025SE |
| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)OXO · Traditional | Hefei Chimed Intelligent Machine Co., Ltd. | 11/06/2025SE |
| K250587 | Orthoscan TAU Mini C-ArmOXO · Special | Ziehm-Orthoscan, Inc. | 07/02/2025SE |
| K243452 | Orthoscan VERSA Mini C-ArmOXO · Traditional | Ziehm-Orthoscan, Inc. | 01/14/2025SE |
| K240828 | OEC One ASDOXO · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 12/27/2024SE |
| K233669 | Oec 3DOXO · Traditional | Ge Oec Medical Systems, Inc. | 03/28/2024SE |
| K213113 | Orthoscan Tau Mini C-ArmOXO · Special | Orthoscan, Inc. | 10/21/2021SE |
| K203346 | Oec 3DOXO · Traditional | Ge Oec Medical Systems, Inc. | 03/05/2021SE |
| K192819 | OEC EliteOXO · Special | Ge Oec Medical Systems, Inc. | 11/08/2019SE |
| K190024 | Smart-COXO · Abbreviated | Turner Imaging Systems, Inc. | 09/27/2019SE |
| K183220 | OrthoScan TAU Mini C-ArmOXO · Traditional | Orthoscan, Inc. | 06/21/2019SE |
| K182626 | OEC OneOXO · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 11/16/2018SE |
| K170946 | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V…OXO · Traditional | Skanray Technologies Private Limited | 11/24/2017SE |
| K172550 | OEC EliteOXO · Traditional | Ge Oec Medical Systems, Inc. | 11/16/2017SE |
| K171800 | OEC Elite MiniViewOXO · Special | Ge Hualun Medical Systems Co. , Ltd. | 07/12/2017SE |
| K163429 | B6OXO · Traditional | Beijing East Whale Imaging Technology Co., Ltd. | 01/04/2017SE |
| K160984 | MultiScan G-Arm SystemOXO · Traditional | Beijing East Whale Imaging Technology Co., Ltd. | 07/20/2016SE |
| K160131 | OEC Elite MiniViewOXO · Traditional | Ge Hangwei Medical Systems Co., Ltd. | 06/21/2016SE |
| K160065 | GEMSS Medical System Surgical Mobile Fluoroscopic X-ray SystemOXO · Traditional | Gemss Medical Systems Co., Ltd. | 05/20/2016SE |
| K151280 | MultiScan G-Arm SystemOXO · Special | Beijing East Whale Imaging Technology Co., Ltd. | 09/30/2015SE |
| K141672 | Digiarc 100AU+OXO · Special | Beijing East Whale Imaging Technology Co., Ltd. | 07/31/2014SE |
| K133174 | Orthoscan FD Mini C-ArmOXO · Traditional | Orthoscan, Inc. | 03/28/2014SE |
| K131423 | G-Arm Multiscan SystemOXO · Traditional | Beijing East Whale Imaging Technology Co., Ltd. | 11/07/2013SE |
| K123603 | Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 PrimeOXO · Traditional | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 05/17/2013SE |
| K121303 | Mobile C-ArmOXO · Traditional | Canon Inc. -Medical Equipment Group | 07/26/2012SE |
| K120613 | Oec 9900 EliteOXO · Special | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 04/06/2012SE |
| K120388 | Insight - FD Mini C-Arm Fluoroscopic Imaging SystemOXO · Special | Hologic, Inc. | 04/06/2012SE |
| K113708 | Orthoscan Mobile Di Mini C-ArmOXO · Traditional | Orthoscan, Inc. | 01/05/2012SE |
| K092564 | O-Arm Imaging SystemOXO · Abbreviated | Medtronic Navigation, Inc. (Littleton) | 06/17/2010SE |
| K061873 | Vert-XOXO · Traditional | Direx Systems Corp. | 08/18/2006SE |
| K060344 | O-Arm Imaging SystemOXO · Traditional | Breakaway Imaging, LLC | 03/29/2006SE |
| K051754 | Orthoscan, Orthoscan HDOXO · Traditional | Orthoscan, Inc. | 08/09/2005SE |
| K051490 | GE Oec Everview 7500OXO · Traditional | Ge Oec Medical Systems, Inc. | 07/07/2005SE |
| K051133 | Arcadis AvanticOXO · Traditional | Siemens Medical Solutions USA, Inc. | 06/01/2005SE |
| K050996 | O-Arm Imaging SystemOXO · Abbreviated | Breakaway Imaging, LLC | 05/05/2005SE |
| K043379 | Shimadzu Surgical Mobile C-Arm Imaging X-Ray System, Model WHA-200OXO · Abbreviated | Shimadzu Corp. | 02/17/2005SE |
| K041213 | 3DSCOPEOXO · Special | Direx Systems Corp. | 07/22/2004SE |
| K040347 | Siremobil Iso-C 3DOXO · Traditional | Siemens Medical Systems, Inc. | 03/09/2004SE |
| K040066 | Siremobile C06OXO · Special | Siemens Medical Solutions USA, Inc. | 02/12/2004SE |
| K033066 | Xiscan 4000 Transportable Imaging SystemOXO · Special | Xitec Holdings, LLC | 11/12/2003SE |
| K013426 | Moonray Mobile C-ArmOXO · Traditional | Simad S.R.L. | 03/26/2002SE |
| K010762 | Philips BV LibraOXO · Traditional | Philips Medical Systems, Inc. | 04/02/2001SE |
| K010393 | Apollo Mobile C Arm SystemOXO · Traditional | Cares Built, Inc. | 03/12/2001SE |
| K003837 | Flexiview 8800 Digital Mobile Imaging SystemOXO · Traditional | Ge Oec Medical Systems | 03/12/2001SE |
| K003568 | Xiscan 6000 Imaging SystemOXO · Traditional | Xitec, Inc. | 12/27/2000SE |
| K003266 | Siremobil Iso-C 3DOXO · Traditional | Siemens Medical Solutions USA, Inc. | 12/01/2000SE |
| K993092 | Sonada Ultrasound SystemOXO · Traditional | Sonovision Corp. | 04/14/2000SE |
| K992506 | Mini 6800 Digital Mobile C-ArmOXO · Abbreviated | Ge Dec Medical Systems | 08/19/1999SE |
| K984406 | Xiscan Office Expert Imaging System, Xiscan Surgical Expert Imaging SystemOXO · Traditional | Xitec, Inc. | 02/02/1999SE |
| K982706 | Philips BV300 Series Release 2.1OXO · Traditional | Philips Medical Systems, Inc. | 09/02/1998SE |
| K981131 | Pathfinder Mobile C ArmOXO · Abbreviated | Acoma Medical Imaging, Inc. | 06/26/1998SE |
| K980322 | Accent 16, Accent 22OXO · Traditional | GE Medical Systems | 04/24/1998SE |
| K973598 | Siremobil CO2OXO · Traditional | Siemens Medical Solutions USA, Inc. | 11/10/1997SE |
| K965013 | Digiscope RX-2 (9 Option)OXO · Traditional | Medirex, Inc. | 01/17/1997SE |
| K963093 | Siremobil CompactOXO · Traditional | Siemens Medical Solutions USA, Inc. | 09/03/1996SE |
| K960907 | OrcaOXO · Traditional | Lunar Corp. | 05/20/1996SE |
| K955251 | Oec 902, 901 Nasa II, Oec 902, 901 Nasa I CCD C-ArmOXO · Traditional | Imaging Services, Inc. | 04/12/1996SE |
| K960198 | Digiscope RX-2OXO · Traditional | Medirex, Inc. | 03/12/1996SE |
| K953910 | Philips BV 300 SeriesOXO · Traditional | Philips Medical Systems North America, Inc. | 10/18/1995SE |
| K951765 | Series 6600 Digital Mobile C-ArmOXO · Traditional | Ge Dec Medical Systems | 05/11/1995SE |
| K940294 | Shimadzu Mobile X-Ray SystemsOXO · Traditional | Shimadzu Precision Instruments, Inc. | 03/16/1994SE |
| K935580 | PHF20 20 Mobile C-Arm Image IntensifierOXO · Traditional | Precise Optics | 03/16/1994SE |
| K934700 | Model 90P Portable Medical Diagnostic X-RayOXO · Traditional | Tempo Technology, Inc. | 03/16/1994SE |
| K933431 | Orthotrac Coaxial LaserOXO · Traditional | Trac Medical, Inc. | 10/05/1993SE |
| K933447 | Stenoscop Mobile Fluoroscopic Xray SystemOXO · Traditional | GE Medical Systems | 08/23/1993SE |
| K926056 | 9600 Fluoroscopic Imaging SystemOXO · Traditional | Oec-Diasonics, Inc. | 01/21/1993SE |
| K914748 | Comet C-125OXO · Traditional | Fischer Imaging Corp. | 10/15/1992SE |
| K921255 | Philips BV26 Mobile C-Arm StandOXO · Traditional | Philips Medical Systems, Inc. | 05/18/1992SE |
| K913525 | Mobile X-Ray SystemOXO · Traditional | Siemens Medical Solutions USA, Inc. | 10/23/1991SE |
| K911739 | Swemac Reison Biplanar 300OXO · Traditional | Seemac Reison AB Co. | 10/23/1991SE |
| K910115 | Philips BV-29 Imaging SystemOXO · Traditional | Philips Medical Systems, Inc. | 02/20/1991SE |
| K900967 | Modified Alpha MC-9R C-ArmOXO · Traditional | Instrumentarium Imaging, Inc. | 05/09/1990SE |
| K900193 | MTHF-9R Mobil C-Arm Image Intensifier UnitOXO · Traditional | Imt America, Inc. | 05/09/1990SE |
| K900194 | MTHF-9S Mobil C-Arm Image Intensifier UnitOXO · Traditional | Imt America, Inc. | 05/07/1990SE |
| K896387 | SXT-60F/60M Mobile C Arm X-Ray UnitOXO · Traditional | Toshiba America Medical Systems, In.C | 02/23/1990SE |
| K892934 | 1 Video Tape Recorder Model BK-224 HOXO · Traditional | Perkins Mfg. Co. | 07/20/1989SE |
| K893617 | Mobile C-ArmOXO · Traditional | Acoma Medical Imaging, Inc. | 07/14/1989SE |
| K880518 | Mobile C-Arm Omni 325OXO · Traditional | Fischer Imaging Corp. | 03/09/1988SE |
| K820658 | Lixiscope - or LixiOXO · Traditional | Lixi, Inc. | 05/18/1982SE |
| K760429 | Flouroscope, Mobile C-Arm Image Intens.OXO · Traditional | Varian Assoc., Inc. | 08/23/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1820-2025 Class II | OEC 3DOEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. | GE Medical Systems, LLC | 03/21/2025Open, Classified |
| Z-1819-2025 Class II | OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital…OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. | GE Medical Systems, LLC | 03/21/2025Open, Classified |
| Z-0706-2025 Class II | OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is…Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and… | GE OEC Medical Systems, Inc | 11/21/2024Open, Classified |
| Z-0705-2025 Class II | OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite…Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and… | GE OEC Medical Systems, Inc | 11/21/2024Open, Classified |
| Z-0704-2025 Class II | OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile…Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and… | GE OEC Medical Systems, Inc | 11/21/2024Open, Classified |
| Z-0703-2025 Class II | OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile…Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and… | GE OEC Medical Systems, Inc | 11/21/2024Open, Classified |
| Z-2279-2023 Class II | Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE…Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the… | GE OEC Medical Systems, Inc | 05/15/2023Open, Classified |
| Z-2277-2023 Class II | OEC 9900 Systems with 9-inch Image IntensifierImage intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the… | GE OEC Medical Systems, Inc | 05/15/2023Open, Classified |
| Z-2275-2023 Class II | OEC Flexiview 8800 Systems with 9-inch Image IntensifierImage intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the… | GE OEC Medical Systems, Inc | 05/15/2023Open, Classified |
| Z-2160-2021 Class II | OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage:…There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early… | GE OEC Medical Systems, Inc | 06/10/2021Terminated |
| Z-1932-2019 Class II | Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where…The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a… | Medtronic Navigation, Inc.-Littleton | 05/01/2019Terminated |
| Z-0280-2019 Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | Medtronic Navigation, Inc.-Littleton | 08/30/2018Terminated |
| Z-0279-2019 Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | Medtronic Navigation, Inc.-Littleton | 08/30/2018Terminated |
| Z-0278-2019 Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | Medtronic Navigation, Inc.-Littleton | 08/30/2018Terminated |
| Z-0277-2019 Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | Medtronic Navigation, Inc.-Littleton | 08/30/2018Terminated |
| Z-0276-2019 Class II | O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | Medtronic Navigation, Inc.-Littleton | 08/30/2018Terminated |
| Z-0275-2019 Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | Medtronic Navigation, Inc.-Littleton | 08/30/2018Terminated |
| Z-0274-2019 Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | Medtronic Navigation, Inc.-Littleton | 08/30/2018Terminated |
| Z-0273-2019 Class II | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | Medtronic Navigation, Inc.-Littleton | 08/30/2018Terminated |
| Z-0272-2019 Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | Medtronic Navigation, Inc.-Littleton | 08/30/2018Terminated |
| Z-0271-2019 Class II | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number…Software anomalies were reported to affect the following system functionalities: startup and shutdown… | Medtronic Navigation, Inc.-Littleton | 08/30/2018Terminated |
| Z-0928-2018 Class II | O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM…Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power… | Medtronic Navigation, Inc.-Littleton | 01/25/2018Terminated |
| Z-0261-2018 Class II | Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with…OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices.… | Orthoscan, Inc. | 08/31/2017Terminated |
| Z-0260-2018 Class II | Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with…OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices.… | Orthoscan, Inc. | 08/31/2017Terminated |
| Z-0259-2018 Class II | Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with…OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices.… | Orthoscan, Inc. | 08/31/2017Terminated |
| Z-0258-2018 Class II | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with…OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices.… | Orthoscan, Inc. | 08/31/2017Terminated |
| Z-1469-2017 Class II | OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical SystemsOEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging… | GE OEC Medical Systems, Inc | 02/21/2017Terminated |
| Z-0975-2017 Class II | The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and…GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC… | GE OEC Medical Systems, Inc | 12/19/2016Terminated |
| Z-0974-2017 Class II | OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is…GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC… | GE OEC Medical Systems, Inc | 12/19/2016Terminated |
| Z-0071-2017 Class II | OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The…GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685… | GE OEC Medical Systems, Inc | 09/23/2016Terminated |
| Z-2082-2016 Class II | Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028It has been discovered that replacement x-ray generator and system motion batteries could become damaged… | Medtronic Navigation, Inc.-Littleton | 03/17/2016Terminated |
| Z-0194-2015 Class II | FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging…GE Healthcare initiated a field correction because prior revision of components were potentially installed… | GE OEC Medical Systems, Inc | 10/03/2014Terminated |
| Z-0193-2015 Class II | OEC MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the…GE Healthcare initiated a field correction because prior revision of components were potentially installed… | GE OEC Medical Systems, Inc | 10/03/2014Terminated |
| Z-0841-2015 Class II | GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications…mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray… | GE OEC Medical Systems, Inc | 09/15/2014Terminated |
| Z-0840-2015 Class II | GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications…mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray… | GE OEC Medical Systems, Inc | 09/15/2014Terminated |
| Z-1638-2015 Class II | GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser… | GE OEC Medical Systems, Inc | 05/22/2014Terminated |
| Z-0066-2014 Class II | GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC…GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high… | GE Healthcare Beijing , Hangwei Medical… | 09/18/2013Terminated |
| Z-0973-2014 Class II | Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and…Review of on-system electronic product labeling and Instructions for comply with applicable Use in response… | Medtronic Navigation, Inc. | 07/25/2013Terminated |
| Z-0926-2013 Class II | Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray…Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the… | Medtronic Navigation, Inc. | 01/31/2013Terminated |
| Z-0200-2013 Class II | GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head…It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product… | GE Healthcare, LLC | 09/20/2012Terminated |
| Z-0199-2013 Class II | GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human…It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product… | GE Healthcare, LLC | 09/20/2012Terminated |
| Z-0198-2013 Class II | GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human…It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product… | GE Healthcare, LLC | 09/20/2012Terminated |
| Z-0197-2013 Class II | GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic…It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product… | GE Healthcare, LLC | 09/20/2012Terminated |
| Z-2244-2012 Class II | Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R…A fault in a high voltage relay in the 0-arm Imaging System might cause the relay to overheat and burn. | Medtronic Navigation, Inc. | 07/11/2012Terminated |
| Z-2241-2012 Class II | GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp…GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to… | GE OEC Medical Systems, Inc | 04/26/2010Terminated |
| Z-2262-2012 Class II | GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope…GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of… | GE OEC Medical Systems, Inc | 10/10/2008Terminated |
| Z-2027-2012 Class II | OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient…Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues… | GE OEC Medical Systems, Inc | 11/19/2007Terminated |
| Z-2065-2012 Class I | OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage:…Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues… | GE OEC Medical Systems, Inc | 11/20/2006Terminated |
| Z-2040-2012 Class I | OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic…Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues… | GE OEC Medical Systems, Inc | 11/20/2006Terminated |