Reported Aug 12, 2020 · Terminated
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor…
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 ONE, Physiological
- Patient Monitor - Product Usageis both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility
- Lot codes and dates
- Model2087075-001
- Serial Numbers
296 of 296 codes
SNA20210164SASNA20210031SASNA20210045SASNA20210064SASNA20210319SASNA20210330SASNA20210348SASNA20210361SASNA20210362SASNA20210375SASNA20210376SASNA20210377SASNA20220003SASNA20220005SASNA20220007SASNA20220018SASNA20220022SASNA20220026SASNA20220045SASNA20220047SASNA18140024SASNA18340072SASNA18370025SASNA18380001SASNA18390009SASNA18430002SASNA18430059SASNA18430088SASNA18430116SASNA19390023SASNA19400056SASNA19400143SASNA19440048SASNA19440069SASNA19440071SASNA19440122SASNA19450008SASNA19450025SASNA19450128SASNA19450136SASNA19500072SASNA19500073SASNA19500080SASNA19500084SASNA19500086SASNA19510001SASNA19510005SASNA19510007SASNA19510012SASNA19510027SASNA19510053SASNA19510055SASNA19510103SASNA20020119SASNA20030070SASNA20030071SASNA20170022SASNA20170080SASNA20170082SASNA20170112SA
- Amount recalled
- 8,414 units
Where it was sold
Why it was recalled
CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.
This product could cause temporary or reversible health problems — stop using it.
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