Infant Warmer System — Class II medical device recall Z-1015-2017
Terminated recall by GE Healthcare, LLC, reported 2017-01-18. GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Hea
| Recall number | Z-1015-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2016-08-04 |
| Classified | 2017-01-11 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2018-07-12 |
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.