Infant Warmer System (IWS)
Published January 18, 2017 · Recall initiated: August 4, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- This product has been distributed domestically and internationally .
- Lot
- Medical device listing number: D103053, D103054, D103056, D103057, D183529
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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