Reported Jan 22, 2020 · Terminated
CARESCAPE Respiratory Module E-sCOVX
GE Healthcare, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 Respiratory Module E-sCOVX
- Lot codes and dates
- Mfg. Lot or Serial # UDI # SGV19276034HA 010084068210428921SGV19276034HA11190702 SGV19266019HA 010084068210428921SGV19266019HA11190626 SGV14404046HA Not Applicable
- Amount recalled
- 3 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was recalled
Stop using this product now
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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