Reported Oct 15, 2014 · Terminated
GE Healthcare Carescape Patient Data Module
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare Carescape Patient Data Module
- Lot codes and dates
- Mfg Lot or Serial #
2,172 of 2,172 codes
SA307020379GRSA307020383GRSA307020386GRSA307020391GRSA307020393GASA307020396GASA307020397GASA307020399GRSA307020400GASA307030405GRSA307030411GRSA307030412GRSA307030413GRSA307030417GASA307030419GASA307030420GASA307030423GASA307050429GASA307070436GRSA307070438GRSA307070441GRSA307070442GRSA307070446GASA307070447GRSA307070448GASA307070449GRSA307070450GRSA307070453GRSA307070454GRSA307070455GRSA307080459GASA307080462GRSA307080463GRSA307080466GASA307080467GASA307080469GASA307080472GASA307080473GRSA307080477GRSA307080478GRSA307080484GASA307080488GASA307080489GASA307080491GASA307080493GRSA307080497GASA307080498GRSA307080499GASA307080502GRSA307080504GRSA307080508GRSA307080509GASA307080510GRSA307080513GASA307080520GRSA307080521GASA307080522GRSA307080524GASA307080525GRSA307080526GR
- Mfg Lot or Serial #
- Amount recalled
- 68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown)
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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