Reported Jul 1, 2020 · Ongoing
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and…
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?
- CARESCAPE Patient Data Module (PDM)
- used with the following monitors
CARESCAPE B450/B650/B850SOLAR 8000M/I and Transport Pro
- Model NumbersTo be provided
64 of 64 codes
2042084-0012094504-0012042084-001-0460502042084-001-2086212042084-001-0459152042084-001-2151642042084-001-0784742042084-001-0530342042084-001-2151652042084-001-0794622042084-001-0473892042084-001-1121982042084-001-0416732042084-001-2272382042084-001-0715642042084-001-5038242042084-001-1198392042084-001-5692692042084-001-0416742042084-001-0475492042084-001-5146512042084-001-1635722042084-001-5837212042084-001-4275922042084-001-5273582042084-001-5837232042084-001-3171662042084-001-5837242042084-001-5837152042084-001-5837182042084-001-0551562042084-001-5837222042084-001-0418352042084-001-0741242042084-001-5837062042084-001-5837072042084-001-5199262042084-001-5837172042084-001-5837132042084-001-2078632042084-001-4606042042084-001-0791922042084-001-1976632042084-001-0458722042084-001-0531952042084-001-0920102042084-001-5608242042084-001-0523722042084-001-0710882042084-001-0466672042084-001-2130062042084-001-0862022042084-001-3018212042084-001-0457202042084-001-0604542042084-001-4182942042084-001-0889072042084-001-0657692042084-001-5895302042084-001-623792
2042084-001-0828252042084-001-0570162042084-001-1536012042084-001-1615522042084-001-1402292042084-001-6117042042084-001-6266882042084-001-3892082042084-001-6578362042084-001-2252142042084-001-5031622042084-001-4778812042084-001-3160252042084-001-0468262042084-001-2452552042084-001-1965432042084-001-5577252042084-001-5058902042084-001-2185962042084-001-3369802042084-001-5245252042084-001-6000322042084-001-5297322042084-001-1957422042084-001-1957822042084-001-5738892042084-001-5738902042084-001-5738862042084-001-5738872042084-001-1958222042084-001-1958622042084-001-0484202042084-001-0655382042084-001-0558142042084-001-3412602042084-001-1492202042084-001-0791932042084-001-2292822042084-001-6294862042084-001-0586952042084-001-0611702042084-001-6295482042084-001-0808032042084-001-5966622042084-001-2501462042084-001-2025152042084-001-5157092042084-001-5794912042084-001-5056082042084-001-0650102042084-001-619171
- Lot codes and dates
- All Model Numbers that contain software versions 2.6 or 2.7
- Amount recalled
- 89,109 units
Why it was recalled
The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG waveform and alarm Asystole to be displayed on the monitor.
This product could cause temporary or reversible health problems — stop using it.
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