Infant Warmer System (IWS)
Reported: June 21, 2017 Initiated: May 5, 2017 #Z-2323-2017
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 34986
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Infant Warmer System (IWS). Recalled by GE Healthcare, LLC. Units affected: 34986.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2323-2017.
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