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

Recall Z-2235-2020 — Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.

U.S. FDA — Device Enforcement · United States · 2020-04-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2235-2020
Date of alert
2020-04-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
66000849
Reported risk: Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.
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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