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GE Healthcare, LLC recalls Infant Warmer System (IWS)
Recalled January 18, 2017 · FDA recall Z-1015-2017 · GE Healthcare
Hazard
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. · FDA Class II
Units
32,073 (US = 24,361; OUS = 7,712)
Sold at
This product has been distributed domestically and internationally .
Description
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.
Product
Infant Warmer System (IWS)
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →