Reported Sep 25, 2013 · Terminated
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
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 Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
- Lot codes and dates
- Serial Number
636 of 636 codes
66179676617968661796966191576619158661915966191606626633662663466372876660104669398067205966720597672059867205996739266CZC0044VY8CZC0044VYLCZC0044VYYCZC0044VZ1CZC0044VZ5CZC0044VZ6CZC0044VZ7CZC0044VZ8CZC0044VZBCZC0070P7BCZC0070P7GCZC0133FMMCZC0133FMSCZC0133FN7CZC0182JL2CZC0182JL8CZC02211YNCZC0249CL3CZC0249CL5CZC0249CL7CZC0249CLFCZC0249CLKCZC03336CTCZC03336D1CZC03336D6CZC0334KJ5CZC0334KJ6CZC0366ZR0CZC0468W4HCZC1027W82CZC1027W85CZC1027W86CZC1027W8CCZC1129Z65CZC116B2N7CZC9313455CZC0016T0HCZC0016T0TCZC0044VY7CZC0044VY9CZC0044VYDCZC0044VYMCZC0044VYP
- Serial Number
- Amount recalled
- 636 (53 US, 583 OUS)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th
This product could cause temporary or reversible health problems — stop using it.
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