Agency classClass IIOur severity:Severe FDA (Devices)·Z-1015-2017·Announced 2017-01-18

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 injury 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) under the rubric.

Plain-English summary

GE Healthcare, LLC is recalling 32,073 Infant Warmer Systems (IWS) due to a potential safety issue involving loose screws in the Heater Head. The recall covers units distributed domestically and internationally, with 24,361 units in the US and 7,712 units outside the US. The affected medical device listing numbers are D103053, D103054, D103056, D103057, and D183529.

The recall is necessary because hot screws from the Heater Head could fall onto the bed if the assembly has been improperly serviced. This situation is clinically hazardous because the falling hot screws could 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 loose screws and ensure the safety of patients using these devices.

The recalled product

Product: Infant Warmer System (IWS)
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Infant Warmer
Hazard: burn-injury
loose-parts

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

Distribution scope not specified by the agency.

Same manufacturer · GE Healthcare, LLC

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