Z-1015-2017Class II

Infant Warmer System (IWS)

Name: Z-1015-2017 Infant Warmer System (IWS)
Creator: GE Healthcare, LLC
Published: 2016-08-04
License: https://open.fda.gov/license/

GE Healthcare / initiated 2016-08-04 / Terminated

FDA source

GE Healthcare, LLC began a recall of Infant Warmer System (IWS) on 2016-08-04. 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-1015-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-04
Posted: 2017-01-11
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: Use error
Action: This recall strategy includes the depth of the recall, plan for public warning and effectiveness check. The strategy outlined below addresses these elements for this particular recall. The plan for public warning is to contact all customers with potentially affected product by means of an Urgent Medical Device Correction letter. The letter will instruct customers that they can continue to use the device by following instructions on the Addendum to the Service Manual. The Service Manual Addendum provides instructions for checking and tightening the screws. In the US the letter will be sent by a traceable means [either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX]. This letter will be sent to: Nurse Manager, Labor & Delivery/NICU; Manager, Bio-Medical Engineering; and Director of Risk Management.
Quantity in commerce: 32,073 (US = 24,361; OUS = 7,712)
Distribution: This product has been distributed domestically and internationally .
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-1015-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1015-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11

Product code FMT

K963058Class IIInfant Warmer SystemOhmeda Medical / cleared 1996-10-01

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)