GE Healthcare Recalls Infant Warmer Systems Due to Loose Heater Screws
GE Healthcare is recalling Infant Warmer Systems because loose screws in the heater head could fall and cause thermal injuries to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reported injuries (thermal burns), which meets the criteria for a Severe rating (Score 4) involving significant injury reports.
Plain-English summary
GE Healthcare, LLC is recalling the Infant Warmer System (IWS) due to a potential safety issue involving loose screws in the 'Heater Head' component. The recall covers 34,986 units distributed nationwide in the United States and worldwide.
The hazard arises if the 'Heater Head' assembly has been improperly serviced, which can cause hot screws to fall onto the bed. This situation is clinically hazardous because it can result in thermal injury to a patient. Two injuries have been reported as a result of this issue.
Healthcare facilities should contact GE Healthcare for instructions on how to address the defect. Consumers and patients should not use the affected devices until they have been properly serviced or replaced according to the manufacturer's guidance.
The recalled product
- Product
- Infant Warmer System (IWS)
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 34,986
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Medical device listing number: D103053
- D103054
- D103056
- D103057
- D183529
Distribution
Distributed nationwide across the United States.
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