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

Recall Z-1015-2017 — Infant Warmer System (IWS)

U.S. FDA — Device Enforcement · United States · 2016-08-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1015-2017
Date of alert
2016-08-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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