Display, Cathode-Ray Tube, Medical
FDA product code DXJ · Class II (moderate risk) · 21 CFR 870.2450 · Cardiovascular
78510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Hewlett-Packard Co. 7
- Vidco, Inc. 5
- Barco N.V. 5
- Litton Medical Electronics 5
- Honeywell, Inc. 4
- Marquette Electronics, Inc. 3
- ZOLL Medical Corporation 3
- Nihon Kohden America, Inc. 3
- Philips Medizin Systeme Boeblingen GmbH 3
- Quinton, Inc. 3
- Shenyang Torch-Bigtide Digital Technology Co., Ltd. 2
- Philips Medical Systems 2
- Siemens Medical Solutions USA, Inc. 2
- Sorin Group Deutschland GmbH 2
- Spacelabs Medical, Inc. 2
- Ge Medical Systems Information Technologies 2
- Burkick Corp. 1
- General Devices 1
- Livanova Deutschland, GmbH 1
- Mennen Greatbatch Electonics 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212003 | ESSENZ Patient MonitorDXJ · Special | Livanova Deutschland, GmbH | 11/10/2021SE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 09/30/2021SE |
| K201162 | Essence 55SP Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 08/27/2020SE |
| K173107 | Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional | Vios Medical, Inc. | 07/26/2018SE |
| K180534 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/16/2018SE |
| K173381 | Nexxis ORDXJ · Special | Barco N.V. | 02/22/2018SE |
| K172969 | Essence 55S Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 01/26/2018SE |
| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
| K161880 | NIVR58-T kitDXJ · Special | Barco N.V. | 03/14/2017SE |
| K161767 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 01/27/2017SE |
| K162012 | CARESCAPE Central Station V2DXJ · Special | GE Healthcare | 09/15/2016SE |
| K151366 | Philips CS770 IntelliSpace Critical Care and AnesthesiaDXJ · Traditional | Philips Medical Systems | 10/30/2015SE |
| K151736 | Philips IntelliVue GuardianSoftwareDXJ · Special | Philips Medizin Systeme Boblingen GmbH | 10/21/2015SE |
| K133994 | SIVR56-T KitDXJ · Traditional | Barco N.V. | 12/01/2014SE |
| K133882 | Carescape Central Station (Formally Known AS Cic Pro)DXJ · Traditional | Ge Medical Systems Information Technologies, Inc. | 04/30/2014SE |
| K132488 | Zoll Code WriterDXJ · Traditional | ZOLL Medical Corporation | 04/03/2014SE |
| K131272 | Siren Epcr SuiteDXJ · Traditional | Medusa Medical Technologies, Inc. | 01/03/2014SE |
| K131919 | Zoll Epcr IosDXJ · Special | ZOLL Medical Corporation | 12/17/2013SE |
| K131816 | Sorin Connect Data Management SystemDXJ · Traditional | Sorin Group Deutschland GmbH | 07/23/2013SE |
| K122167 | Nexxis orDXJ · Traditional | Barco N.V. | 04/22/2013SE |
| K113214 | Tlink Data Management System (DMS)DXJ · Traditional | Terumo Cardiovascular Systems Corp. | 02/07/2012SE |
| K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…DXJ · Abbreviated | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 10/04/2011SE |
| K112645 | Radiforce Large Monitor SystemDXJ · Traditional | Eizo GmbH | 09/22/2011SE |
| K103473 | Zoll Rescuenet Epcr Model Rescuenet EpcrDXJ · Traditional | ZOLL Medical Corporation | 05/13/2011SE |
| K110085 | Vantage View SystemDXJ · Traditional | St Jude Medical | 01/26/2011SE |
| K101474 | MD Vision SystemDXJ · Traditional | Perkins Healthcare Technologies | 07/02/2010SE |
| K100272 | Intellivue Clinical Information PortfolioDXJ · Special | Philips Medical Systems | 04/14/2010SE |
| K083321 | Cardio-ViewDXJ · Traditional | Curlview Igt, LLC | 11/26/2008SE |
| K073372 | Electrophysiology Systems Integrator (Epsi)DXJ · Traditional | Systemsone | 12/07/2007SE |
| K053356 | Modification to: Cic Pro Clinical Information Center Central StationDXJ · Traditional | Ge Medical Systems Information Technologies | 04/19/2006SE |
| K013515 | Infinity ExplorerDXJ · Traditional | Siemens Medical Solutions USA, Inc. | 01/10/2002SE |
| K001112 | GE Marquette Clinical Information Center, GE Marquette CicDXJ · Traditional | General Electric Medical Systems Information Techn | 06/14/2000SE |
| K992636 | HP Carevue 9000 Clinical Information System, Model M2331ADXJ · Special | Hewlett-Packard Co. | 08/31/1999SE |
| K942685 | ECG Review StationDXJ · Traditional | Mortara Instrument, Inc. | 08/12/1997SE |
| K962811 | Spacelabs Medical Multi-Disclosure WorkstationDXJ · Traditional | Spacelabs Medical, Inc. | 06/24/1997SE |
| K945277 | Hewlett-Packard Model M1490A Wireless Patient Data CommunicatorDXJ · Traditional | Hewlett-Packard Co. | 01/30/1995SE |
| K934093 | 580CDR Display DriverDXJ · Traditional | Vidco, Inc. | 08/18/1994SE |
| K932894 | 620CSR Display DriverDXJ · Traditional | Vidco, Inc. | 06/20/1994SE |
| K926219 | 516YT Display DriverDXJ · Traditional | Vidco, Inc. | 12/16/1993SE |
| K926162 | 580CD Display DriverDXJ · Traditional | Vidco, Inc. | 11/08/1993SE |
| K932724 | Spacelabs Medical Integrated Clinical DisplayDXJ · Traditional | Spacelabs Medical, Inc. | 11/05/1993SE |
| K905788 | Model M1251A Mon. Full Disclosure Review SystemDXJ · Traditional | Hewlett-Packard Co. | 06/06/1991SE |
| K901072 | Centralscope 12DXJ · Traditional | Marquette Electronics, Inc. | 08/23/1990SE |
| K902334 | Monitor, Model 2817DXJ · Traditional | Esaote Biomedica Spa | 06/26/1990SE |
| K901884 | 7620 Remote Central Station RepeaterDXJ · Traditional | Marquette Electronics, Inc. | 06/12/1990SE |
| K884423 | Horizon Display Controller Part # 266-200-010DXJ · Traditional | Mennen Medical, Inc. | 05/31/1989SE |
| K890353 | SMDS460 Surgical Monitor Display SystemDXJ · Traditional | Vidco, Inc. | 03/02/1989SE |
| K883973 | Model VY-800RA Optional Accessory to BSM 8500ADXJ · Traditional | Nihon Kohden America, Inc. | 11/09/1988SE |
| K883031 | Q-Cath RMDXJ · Traditional | Quinton, Inc. | 09/20/1988SE |
| K873774 | M300 Monitor/Controller T500 TreadmillDXJ · Traditional | Burdick Corp. | 11/06/1987SE |
| K854372 | VM 781 Slave ScopeDXJ · Traditional | Nihon Kohden America, Inc. | 02/28/1986SE |
| K851496 | ECG Monitor Model RM102DXJ · Traditional | Honeywell, Inc. | 07/24/1985SE |
| K851628 | RMG-9 9 Remote Monitor Access. for G-2000 ElectroDXJ · Traditional | Eaton Medical Group | 06/27/1985SE |
| K851400 | Sirecust 420 Patient Dialog MonitorDXJ · Traditional | Siemens Medical Solutions USA, Inc. | 06/26/1985SE |
| K850343 | Display Monitor (VD-711RA-VD-712RA)DXJ · Traditional | Nihon Kohden America, Inc. | 04/18/1985SE |
| K844650 | DR-2CDXJ · Traditional | General Devices | 01/22/1985SE |
| K840209 | Servomed Medivision Scope SMV-235DXJ · Traditional | Litton Medical Electronics | 09/20/1984SE |
| K833819 | M305DXJ · Traditional | Burkick Corp. | 05/09/1984SE |
| K832022 | Servomed SMC 108/111-426-24, 111-426DXJ · Traditional | Litton Medical Electronics | 11/16/1983SE |
| K831783 | Servomed Basic Bedside Unit SMV 104DXJ · Traditional | Litton Medical Electronics | 11/16/1983SE |
| K831782 | Servomed Basic Bedside Unit SMV 107DXJ · Traditional | Litton Medical Electronics | 11/16/1983SE |
| K831781 | Servomed Basic Bedside Unit Smviii WDXJ · Traditional | Litton Medical Electronics | 11/16/1983SE |
| K830899 | Three Channel Monitor Series 6700DXJ · Traditional | Marquette Electronics, Inc. | 04/12/1983SE |
| K822517 | Single Channel Nonfade OscilloscopeDXJ · Traditional | Quinton, Inc. | 09/14/1982SE |
| K821491 | 35MM Angiogram Viewer AnalyzerDXJ · Traditional | Birtcher Corp. | 07/08/1982SE |
| K811911 | Single Channel Non-Fade OscilloscopeDXJ · Traditional | Quinton, Inc. | 07/28/1981SE |
| K810168 | Slave Monitors DC109 & VS109DXJ · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K810165 | Dual Trace Video Monitor VM 410DXJ · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K810164 | VC 430 Video ConverterDXJ · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K803123 | CRT Display #1310BDXJ · Traditional | Hewlett-Packard Co. | 01/13/1981SE |
| K801000 | Large Screen CRT Display #1311BDXJ · Traditional | Hewlett-Packard Co. | 05/28/1980SE |
| K781256 | Cathode Ray Tube Med. DisplayDXJ · Traditional | Rae Medical Corp. | 09/20/1978SE |
| K780782 | M. 1336S Cathode-Ray Tube DisplayDXJ · Traditional | Hewlett-Packard Co. | 06/14/1978SE |
| K780425 | Biophysical Monitoring SystemDXJ · Traditional | Gould, Inc. | 04/28/1978SE |
| K770279 | Monitor, Portable, Part #431-010DXJ · Traditional | Mennen Greatbatch Electonics | 02/24/1977SE |
| K760721 | Medical Oscilloscope Memory ScopeDXJ · Traditional | Abbott Laboratories | 10/06/1976SE |
| K760523 | Monitor ScopeDXJ · Traditional | Hewlett-Packard Co. | 09/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0214-2026 Class II | GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version…Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot… | Wipro GE Healthcare Private Ltd. | 09/05/2025Open, Classified |
| Z-0213-2026 Class II | GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version…Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot… | Wipro GE Healthcare Private Ltd. | 09/05/2025Open, Classified |
| Z-1994-2025 Class II | Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331…Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or… | Barco N.V. | 05/09/2025Open, Classified |
| Z-2332-2024 Class II | MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube displayWe have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when… | Barco N.V. | 04/24/2024Completed |
| Z-1854-2022 Class II | Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a)…installation issues | Barco NV | 07/27/2022Open, Classified |
| Z-1265-2022 Class II | CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update…The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This… | GE Healthcare, LLC | 05/10/2022Open, Classified |
| Z-0808-2022 Class II | GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF…If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting… | GE Healthcare, LLC | 01/28/2022Open, Classified |
| Z-3111-2011 | Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209…Under certain circumstances, edits to an order can result in unintended scheduled interventions on the… | Philips Healthcare Inc. | 07/08/2011Terminated |
| Z-0414-2011 | Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System…Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through… | Philips Healthcare Inc. | 10/19/2010Terminated |
| Z-0649-2010 | Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors…Potential for monitor to shut down and not being able to power on again. | Spacelabs Healthcare, Incorporated | 11/06/2009Terminated |
| Z-0648-2010 | Spacelabs Model 91369-24 SL 2400 Compact Monitor Spacelabs Medical patient monitors…Potential for monitor to shut down and not being able to power on again. | Spacelabs Healthcare, Incorporated | 11/06/2009Terminated |
| Z-0647-2010 | Spacelabs Model 91367 SL 2200 Compact Monitor Spacelabs Medical patient monitors…Potential for monitor to shut down and not being able to power on again. | Spacelabs Healthcare, Incorporated | 11/06/2009Terminated |
| Z-0288-2011 | The product is a 19" Spacelabs Medical Flat Panel Display, Model 94260-19, manufactured…The Spacelabs Medical Flat Panel Display, Model 94260-19 may fail prematurely and causing the screen to go… | Spacelabs Healthcare, Incorporated | 10/23/2009Terminated |
| Z-0418-2010 | IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02.…A software defect exists in the ICIP Release 0.02 scheduling function for order management such that if a… | Philips Healthcare Inc. | 10/21/2009Terminated |
| Z-1654-2009 | Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data…Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders' original… | Philips Healthcare Inc. | 05/05/2009Terminated |
| Z-1436-2009 | CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection…Software: A software defect under certain circumstances could lead to the unintended administration of a… | Philips Healthcare Inc. | 05/05/2009Terminated |
| Z-0620-2011 | Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film…The power supply of the Spacelabs Medical Flat Panel Display may fail, causing the display to go blank. | Spacelabs Healthcare, Llc | 03/20/2009Terminated |
| Z-1541-2008 | IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00…Medications prescribed for one patient were printed on the record of another patient. | Philips Medical Systems | 03/04/2008Terminated |
| Z-1540-2008 | CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This…Medications prescribed for one patient were printed on the record of another patient. | Philips Medical Systems | 03/04/2008Terminated |