Reported Feb 19, 2020 · Ongoing
Respironics V680 Ventilator, Service # 850011, (OUS Only)
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 V680 VentilatorService # 850011(OUS Only)
- Lot codes and dates
- Serial Numbers
190 of 190 codes
100255874100255957100257487100257488100257490100257491100257493100257494100257495100257496100257497100257498100257499100257500100257501100258060100258061100258063100258064100258065100258066100258067100258068100260220100260221100260222100260223100260224100260227100260228100260229100260616100260617100260618100260619100260620100260621100260622100260623100260624100260625100260626100260627100260628100260629100260630100260631100260632100260633100260634100260635100261843100261844100261845100261846100261847100261848100261849100261850100261851
- Serial Numbers
- Amount recalled
- 190
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 touchcreen, 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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