Reported Feb 19, 2020 · Ongoing
Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451,…
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 RP-UI Assy, V60 Ventilators User Interface RP-Kits
- REF/P/N
453561528931453561528941453561536451453561536461
- Lot codes and dates
- Serial Numbers
100270400100270407100256220100270404100263004100266507100270402100263001100263009100258193100258197100258883100262978100263006100258196100256196100256197100256198100263003100266499100266505100258889100256192100258887100266509100270408100262976100258881100258880100266511100270406100258885100256223100263000100258884100258888100266500100266504100258886100256222100256195100256199100266502100266508100266510100270403100270490100257708100257713100257716100256831100256834100256837100262373100262556100262575100265136
- Serial Numbers
- Amount recalled
- 56
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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