🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: August 9, 2024 Wipro GE Healthcare Private Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Wipro GE Healthcare Private Ltd.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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.

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3081-2024

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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.

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