Z-2323-2017 Class II Terminated
FDA device recall Z-2323-2017 was initiated by GE Healthcare, LLC on May 5, 2017 and is designated Class II. 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 coul… The recall status is terminated (terminated July 12, 2018). Affected quantity: 34986.
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