Z-3080-2024Class II

GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a...

Name: Z-3080-2024 GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a...
Creator: Wipro GE Healthcare Private Ltd.
Published: 2024-08-09
License: https://open.fda.gov/license/

Wipro GE Healthcare Private Ltd. / initiated 2024-08-09 / Open, Classified / root cause: manufacturing process

FDA source

Wipro GE Healthcare Private Ltd. began a recall of GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to... on 2024-08-09. FDA classified it as Class II and gives the reason as "GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3080-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-09
Posted: 2024-09-20
Recalling firm: Wipro GE Healthcare Private Ltd.
Product: GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
Product code: FMT Warmer, Infant Radiant
Reason for recall: GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 08/09/2024 by letter disseminated through a traceable means. The notice explained the safety issue and the potential for adverse impact to user or patient. The notice also provided information for the safe operation of the device until GE Healthcare is able to inspect and test the units. A GE Healthcare representative will contact the consignee to arrange for the correction. Questions: Contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 1
Distribution: US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom.
Product codes and lots: Serial Number GBW24230381SA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3080-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3080-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3081-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20

Product code FMT

K201628Class IIPanda iRes Warmer, Giraffe WarmerGE Healthcare / cleared 2021-02-12

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)