Reported Sep 2, 2020 · Terminated
CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled,…
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 R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
- Lot codes and dates
- CARESCAPE R8601506-8600-000
- Spare partsCARESCAPE
- R860
1505-3215-0002071409-S2071410-001
- Engstrom
2,007 of 2,007 codes
M1115997-SM1081816-S Identifier # CBRZ03152CBRZ03159CBRZ03171CBRZ03173CBRZ03174CBRZ03175CBRZ03176CBRZ03177CBRZ03180CBRZ03182CBRZ03867CBRZ03869CBRZ03870CBRZ03873CBRZ03856CBRZ03259CBRZ03261CBRZ03263CBRZ03264CBRZ03265CBRZ03267CBRZ03274CBRZ03275CBRZ03278CBRZ03281CBRZ03928CBRZ03946CBRZ03989CBRZ03990CBRZ03994CBRZ03845CBRZ03857CBRZ03858CBRZ03861CBRZ03868CBRZ03872CBRZ03879CBRZ03880CBRZ03881CBRZ03883CBRZ03889CBRZ03890CBRZ03891CBRZ03484CBRZ03485CBRZ03487CBRZ03488CBRZ03490CBRZ03502CBRZ03793CBRZ03842CBRZ03843CBRZ03849CBRZ03850CBRZ03851CBRZ03853CBRZ03864CBRZ03865CBRZ03866
- Amount recalled
- 2277 units
Why it was recalled
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
This product could cause temporary or reversible health problems — stop using it.
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