FDA recall Z-2323-2017

Product

Infant Warmer System (IWS)

Reason for recall

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.

Distribution

Worldwide Distribution - USA (nationwide) Distribution.

Key facts

Status

Terminated

Initiation date

2017-05-05

Report date

2017-06-21

Termination date

2018-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2323-2017