medical Class II Updated 2020-02-19

Respironics California, LLC recalls Respironics RP-UI Assy, V60 Ventilators User Interface RP-Ki

Recalled Product

Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 100270400, 100270407, 100256220, 100270404, 100263004, 100266507, 100270402, 100263001, 100263009, 100258193, 100258197, 100258883, 100262978, 100263006, 100258196, 100256196, 100256197, 100256198, 100263003, 100266499, 100266505, 100258889, 100256192, 100258887, 100266509, 100270408, 100262976, 100258881, 100258880, 100266511, 100270406, 100258885, 100256223, 100263000, 100258884, 100258888, 100266500, 100266504, 100258886, 100256222, 100256195, 100256199, 100266502, 100266508, 100266510, 100270403, 100270490, 100257708, 100257713, 100257716, 100256831, 100256834, 100256837, 100262373, 100262556, 100262575, 100265136
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