Reported Feb 19, 2020 · Ongoing
Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
Respironics California, 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: Respironics California, LLC · 2271 Cosmos Ct · Carlsbad, CA · 92011-1517
Is this the product you have?
Respironics V60 VentilatorService # 850008
- REF
1053613105361410536171053614
- Lot codes and dates
- Serial Numbers
2,783 of 2,783 codes
100005249100254792100255723100255865100256311100256502100256609100256781100256875100257173100257312100257583100257698100258034100258360100258513100258809100259082100259249100259633100259878100260186100260534100260846100261115100261278100261538100261743100262170100262417100262531100262627100262821100007779100254793100255724100255866100256312100256503100256610100256782100256876100257174100257313100257584100257699100258035100258361100258514100258810100259083100259250100259634100259879100260231100260535100260847100261117100261279100261539
- Serial Numbers
- Amount recalled
- 2851
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
This product could cause temporary or reversible health problems — stop using it.
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