FDA Device recall Z-3081-2024
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518 by Wipro Ge Healthcare Private, citing 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 electri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3081-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-09 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Wipro Ge Healthcare Private |
| Distribution | n/a |
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
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.
Identifiers
| code_info | 1) M1112198-01045518, UDI/DI 00840682152709, Serial Numbers: PBW23420278SA, PBW23390175SA, PBW24241071SA, PBW24241072S…1) M1112198-01045518, UDI/DI 00840682152709, Serial Numbers: PBW23420278SA, PBW23390175SA, PBW24241071SA, PBW24241072SA, PBW24241075SA, PBW23340090SA; 2) M1112198-01045579, UDI/DI 00840682152709, Serial Numbers: PBW24241078SA, PBW24241079SA, PBW24241063SA, PBW24241076SA; 3) M1112198-01047148, UDI/DI 00840682152709, Serial Numbers: PBW24241068SA, PBW24241070SA, PBW24241065SA, PBW24241064SA, PBW24241066SA, PBW24241067SA, PBW24241069SA; 4) M1112198-01047271, UDI/DI 00840682152716, Serial Numbers: PBW23492144SA, PBW23482075SA, PBW23492149SA, PBW24062087SA, PBW24062078SA, PBW24062081SA, PBW23492145SA, PBW24152231SA, PBW24152225SA, PBW24152229SA, PBW23482085SA, PBW24202294SA, PBW24202292SA, PBW24202293SA, PBW24212323SA, PBW24212324SA, PBW24152226SA, PBW24152227SA, PBW24052060SA, PBW23492142SA; 5) M1112198-01048731, UDI/DI 00840682152709, Serial Numbers: PBW24241087SA, PBW24241086SA, PBW24241085SA, PBW23320042SA, PBW23320041SA, PBW24241084SA, PBW23320035SA; 6) M1112198-01048740, UDI |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3081-2024%22
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