GE Giraffe Warmer (GE HealthCare) - Electrical Safety Gap (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India
Lot Codes / Batch Numbers
Serial Number GBW24230381SA
Products Sold
Serial Number GBW24230381SA
Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India is recalling GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared h due to GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmer. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026