FDASeptember 11, 2019device

Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C

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

410881808000141213180900014130518110001413791812000141379181202514154018130001416331814000141633181402764172418150001417241815014141838181600014183818160108

Recall history

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

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