Z-2323-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 5, 2017
- Termination Date
- July 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34986
Product Description
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 Pattern
Worldwide Distribution - USA (nationwide) Distribution.
Code Information
Medical device listing number: D103053, D103054, D103056, D103057, D183529