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 | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an |
| Product | GE Healthcare Carescape Patient Data Module |
| Quantity | 68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown) |
| Distribution | Worldwide Distribution: US (nationwide) including DC, PR, Guantanamo except DE, HI, ND, SD & WY; and countries of: SOUTH AFRICA, KOREA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, TRINIDAD TOBAGO, THAILAND, TANZANIA, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, QATAR, BRASIL, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, PARAGUAY, OMAN, NEW ZEALAND, NORW… |
| Initiated | 2014-09-19 |
| Classified | 2014-10-09 |
| Terminated | 2016-09-13 |
| Recall number | Z-0060-2015 |
| 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-0060-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69207/
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