CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

Infant Warmer System (IWS) recalled by GE Healthcare

GE Healthcare is recalling Infant Warmer System (IWS). The recall was initiated on 4 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedical device listing number: D103053, D103054, D103056, D103057, D183529

Quantity recalled32,073 (US = 24,361; OUS = 7,712)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1015-2017
FDA event ID: 75210
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 4 Aug 2016
FDA classified: 11 Jan 2017
Reported: 18 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 Aug 2016	Recall initiated by company
11 Jan 2017	Classified by FDA	+160 days
18 Jan 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Infant Warmer System (IWS)

Where it was distributed

This product has been distributed domestically and internationally .

Questions about this recall

Why was it recalled?

Which lots are affected?

Medical device listing number: D103053, D103054, D103056, D103057, D183529

Where was it sold?

This product has been distributed domestically and internationally .

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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