FDAFDA · Food and drugs·Recall number Z-3081-2024
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.
Published October 2, 2024 · Recall initiated: August 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Wipro GE Healthcare Private Ltd.
- Distributor
- US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom.
- Lot
- 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/DI 00840682152716, Serial Numbers: PBW23482093SA; 7) M1112198-01052386, UDI/DI 00840682152716, Serial Numbers: PBW23482100SA, PBW24202309SA, PBW24202313SA, PBW24202310SA, PBW24202315SA, PBW24202312SA, PBW24202314SA, PBW24202311SA; 8) M1112198-01054697, UDI/DI 00840682152716, Serial Numbers: PBW24132200SA; 9) M1112198-01068942, UDI/DI 00840682152716, Serial Numbers: PBW23472056SA, PBW24062069SA, PBW24112144SA, PBW24062072SA, PBW24112157SA, PBW24112149SA, PBW24112145SA, PBW24112158SA, PBW24112148SA, PBW24112147SA, PBW24112155SA, PBW24112150SA, PBW24112153SA, PBW24112156SA, PBW24112152SA, PBW24112154SA, PBW24112146SA, PBW24112151SA, PBW24142209SA; 10) M1112198-01084972, UDI/DI 00840682152716, Serial Numbers: PBW23462025SA, PBW23462038SA, PBW23462039SA, PBW23472051SA, PBW23472049SA, PBW23472050SA, PBW24132204SA, PBW24132203SA, PBW24132205SA, PBW24122189SA, PBW24122190SA; 11) M1112198-01090848, UDI/DI 00840682152716, Serial Numbers: PBW24122198SA, PBW24122195SA, PBW24122197SA; 12) M1112198-01093457, UDI/DI 00840682152716, Serial Numbers: PBW24202308SA, PBW24132201SA; 13) M1112198-01117766, UDI/DI 00840682152709, Serial Numbers: PBW24110390SA; 14) M1112198-01139893, UDI/DI 00840682152716, Serial Numbers: PBW23242002SA, PBW23242003SA, PBW23242000SA, PBW23242001SA, PBW23512155SA, PBW24062070SA, PBW24172255SA, PBW24172253SA, PBW24172254SA, PBW24172251SA, PBW24172250SA, PBW24212327SA, PBW24212328SA; 15) M1112198-01156745, UDI/DI 00840682152716, Serial Numbers: PBW24192258SA; 16) M1112198-01167230, UDI/DI 00840682152716, Serial Numbers: PBW23462035SA, PBW23462036SA, PBW23462040SA, PBW24112159SA; 17) M1112198-01177090, UDI/DI 00840682152716, Serial Numbers: PBW23482099SA; 18) M1112198-01183599, UDI/DI 00840682152716, Serial Numbers: PBW23492140SA, PBW23482090SA, PBW23482092SA, PBW23482089SA, PBW23482086SA, PBW23492139SA, PBW23482087SA, PBW23482088SA, PBW23482091SA, PBW23482103SA, PBW23482104SA, PBW23482105SA; 19) M1112198-01185372, UDI/DI 00840682152716, Serial Numbers: PBW23482079SA, PBW23482081SA, PBW23482082SA, PBW23482083SA, PBW23482078SA; 20) M1112198-01193801, UDI/DI 00840682152716, Serial Numbers: PBW23502154SA, PBW24172252SA; 21) M1112198-01200764, UDI/DI 00840682152716, Serial Numbers: PBW23472043SA; 22) M1112198-01245548, UDI/DI 00840682152716, Serial Numbers: PBW24062101SA; 23) M1112198-01253742, UDI/DI 00840682152716, Serial Numbers: PBW24052062SA, PBW24052063SA, PBW24052066SA, PBW24052065SA, PBW24052064SA; 24) M1112198-01274059, UDI/DI 00840682152716, Serial Numbers: PBW24192278SA, PBW24192279SA.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- India
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