GE Panda iRES Warmer — Class II medical device recall Z-3081-2024
Ongoing recall by Wipro GE Healthcare Private Ltd., reported 2024-10-02. GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing
| Recall number | Z-3081-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wipro GE Healthcare Private Ltd., Bengaluru, India |
| Recall initiated | 2024-08-09 |
| Classified | 2024-09-20 |
| Reported by FDA | 2024-10-02 |
| Countries outside the US | AE, AU, CH, DE, DK, ES, FR, GB, IE, IT, NZ, PL, PT, SI |
| Quantity | 137 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00840682152709, 00840682152716 |
| Serial numbers | PBW23242000SA, PBW23242001SA, PBW23242002SA, PBW23242003SA, PBW23320035SA, PBW23320041SA, PBW23320042SA, PBW23340090SA, PBW23390175SA, PBW23420278SA, PBW23462025SA, PBW23462035SA, PBW23462036SA, PBW23462038SA, PBW23462039SA, PBW23462040SA, PBW23472043SA, PBW23472049SA, PBW23472050SA, PBW23472051SA, PBW23472056SA, PBW23482075SA, PBW23482078SA, PBW23482079SA, PBW23482081SA and 112 more |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3081-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.