FDASeptember 11, 2019device

Respironics V680 Ventilator, Service # 850011, (OUS Only)

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

Recall history

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

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