Infant Warmer System recall
Infant Warmer System (IWS)
Why was Infant Warmer System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Medical device listing number: D103053, D103054, D103056, D103057, D183529
- Product
- Infant Warmer System (IWS)
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 32,073 (US = 24,361; OUS = 7,712)
- Distribution
- This product has been distributed domestically and internationally .
- Recall date
- January 18, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)