Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1152-2020 — Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614

U.S. FDA — Device Enforcement · United States · 2019-09-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1152-2020
Date of alert
2019-09-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Respironics California, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
100005249
Reported risk: 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 touchscreen, 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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