Infant Warmer System recalled over fire hazard

Recall date

August 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

GE Healthcare, LLC recalls Infant Warmer System (IWS)

Recall number

Z-1015-2017

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

This product has been distributed domestically and internationally .

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Infant Warmer System (IWS)