Recall Z-1265-2022 ยท DXJ Display, Cathode-Ray Tube, Medical
GE Healthcare, LLC
CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #2082293-002, FRU MP200 CPU ASSEMBLY; (4) Part #2071523-001, MP200 22 IN DISPLAY WITH TOUCH; (5) Part #20
| Date | Jun 13, 2022 (initiated May 10, 2022) |
| Status | Open, Classified |
| Reason | The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. |
| Root cause | Process control |
| Action | The recalling firm issued letters flagged URGENT MEDICAL DEVICE CORRECTION dated 5/10/2022 via traceable means. The letter listed the affected product details and described the safety issue and actions to be taken by the customer/user. It said they can continue to use the CSCS V2 to monitor patients on the CARESCAPE Network. In the event there is a loss of patient monitoring at the CSCS V2, they were to follow the safety instructions, which included: Ensure all patients are adequately monitored using other GE Central Stations, with alternate monitoring devices, or with increased patient sur |
| Quantity | 30,993 Central Stations and 2,180 FRUs and displays |
| Distribution | Worldwide distribution - US Nationwide. There was also military/government distribution and the countries of Algeria, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Costa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162012 | CARESCAPE Central Station V2 GE Healthcare, Sep 15, 2016 |