FDA-Device2017-01-18Class II
Infant Warmer System (IWS)
GE Healthcare, LLC
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.
Sold states
This product has been distributed domestically and internationally .
Affected count
32,073 (US = 24,361; OUS = 7,712)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Infant Warmer System (IWS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1015-2017Don't want to check this manually?
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