FDASeptember 11, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

respironics californiarespironics

UPCs

453561528931453561528941453561536451453561536461

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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