Reported Apr 5, 2017 · Terminated
Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60…
Respironics California Inc.
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: Respironics California Inc · 2271 Cosmos Ct · Carlsbad, CA · 92011-1517
Is this the product you have?
- Philips V60 Ventilator with Version 2.20 Software
- DescriptionV 60 Ventilator
- Intl OptCFLEX,AVAPS,PPV V60 Ventilator
- Intl OptCFLEX,AVAPS V60 Ventilator
- Intl OptNone V60 Ventilator
- English OptNone V60 Ventilator
- Engl OptCFLEX,AVAPS
- V60 Us Demo Unit V60 USED ENGL OPTCFLEX, AVAPS,PPV,AT+cl V60 VENT
- JAPAN OPTCFLEX, AVAPS, AT+ V60 VENT
- JAPAN OPT
CFLEXAVAPSAT+ Catalog/REF No. 10536131053614105361510536161053617DU1053617U10536171076709R1076709
- Lot codes and dates
- Serial Number
2,512 of 2,512 codes
100190253100195884201023008201024196201025984201025987201025988201025947201025972201025996201026002201023858201026449201026531201026645201026658201026668201025266201026252201026254201026431201026433201026434201026435201026436201026439201026569201026577201026579201026598201026601201026605201026636201026639201026640201026642201026646201026649201026651201026652201026653201026655201026659201026662201026665201026667201026672201026673201026680201026685201026686201026687201026689201026690201026691201026692201026693201026694201026695201026699
- Serial Number
- Amount recalled
- 2512 units
Why it was recalled
The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E. Ventilatory support will cease.
This product could cause temporary or reversible health problems — stop using it.
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