Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | 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 #2092930-001, DSP LCD 22 IN MED W/TCH W/DKST N AMR; (6) Part #2092930-002, DSP LCD 22 IN MED W/TCH W/DKST BRIT P/C; (7) Part #2092930-003, DSP LCD 22IN MED W/TCH W/DKST EURO P/C; (8) Part #2092930-004, D… |
| 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 Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, … |
| Initiated | 2022-05-10 |
| Classified | 2022-06-13 |
| Recall number | Z-1265-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-1265-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90242/
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