FDA Device recall Z-2323-2017
Infant Warmer System (IWS)
- FDA Device
- Class II
- terminated
- Published 2017-06-21
On 2017-06-21 the FDA classified a Class II recall of Infant Warmer System (IWS) by Ge Healthcare, citing 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 Hea….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2323-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-05 |
| Published | 2017-06-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Infant Warmer System (IWS)
Reason
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.
Identifiers
| code_info | Medical device listing number: D103053, D103054, D103056, D103057, D183529 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2323-2017%22
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