Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GE Panda iRES Warmer Recalled by Wipro GE Healthcare Private Ltd. Due to GE HealthCare has become aware that complete electrical...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Wipro GE Healthcare Private Ltd. directly.
Affected Products
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10) M1112198-01084972; 11) M1112198-01090848; 12) M1112198-01093457; 13) M1112198-01117766; 14) M1112198-01139893; 15) M1112198-01156745; 16) M1112198-01167230; 17) M1112198-01177090; 18) M1112198-01183599; 19) M1112198-01185372; 20) M1112198-01193801; 21) M1112198-01200764; 22) M1112198-01245548; 23) M1112198-01253742; 24) M1112198-01274059. 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.
Quantity: 137 units
Why Was This Recalled?
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.
Where Was This Sold?
US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom.
About Wipro GE Healthcare Private Ltd.
Wipro GE Healthcare Private Ltd. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report