Z-2323-2017Class II

Infant Warmer System (IWS)

Name: Z-2323-2017 Infant Warmer System (IWS)
Creator: GE Healthcare, LLC
Published: 2017-05-05
License: https://open.fda.gov/license/

GE Healthcare / initiated 2017-05-05 / Terminated

FDA source

GE Healthcare, LLC began a recall of Infant Warmer System (IWS) on 2017-05-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2323-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-05
Posted: 2017-05-19
Terminated: 2018-07-12
Recalling firm: GE Healthcare
Product: Infant Warmer System (IWS)
Product code: FMT Warmer, Infant Radiant
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.
FDA root cause: Under Investigation by firm
Action: GE Healthcare sent an Urgent Medical Device Correction letter dated May 5, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Product Correction : Attached to this letter, we provide instructions as part of a Service Manual Addendum on how to correct the issue. Please add this new Addendum to the Service Manual of your device(s) and train the affected users accordingly. Please acknowledge that you have received this letter and that you understand that an action needs to be taken on your part to correct this issue by filling out and returning the attached Customer Response form. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.
Quantity in commerce: 34986
Distribution: Worldwide Distribution - USA (nationwide) Distribution.
Product codes and lots: Medical device listing number: D103053, D103054, D103056, D103057, D183529

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2323-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2323-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-09

Product code FMT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)