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

Recall Z-1560-2022 — Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000

U.S. FDA — Device Enforcement · United States · 2022-07-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1560-2022
Date of alert
2022-07-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Getinge Usa Sales Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
73257100031183
Reported risk: Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and consequently desaturation, with patient outcomes including hypoxemia and hypoxic injury, which might result in circulatory failure.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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