Reported Oct 2, 2024 · Ongoing
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4)…
Wipro GE Healthcare Private Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wipro GE Healthcare Private Ltd. · 122 Part 1 · Bengaluru · N/A
Is this the product you have?
24 of 24 products
| # | Product as published |
|---|---|
| 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 |
- Lot codes and dates
24 of 24 products
Products covered by this recall # Barcodes Product as published 1 00840682152709M1112198-01045518, UDI/DI 00840682152709, Serial Numbers: PBW23420278SA, PBW23390175SA, PBW24241071SA, PBW24241072SA, PBW24241075SA, PBW23340090SA 2 00840682152709M1112198-01045579, UDI/DI 00840682152709, Serial Numbers: PBW24241078SA, PBW24241079SA, PBW24241063SA, PBW24241076SA 3 00840682152709M1112198-01047148, UDI/DI 00840682152709, Serial Numbers: PBW24241068SA, PBW24241070SA, PBW24241065SA, PBW24241064SA, PBW24241066SA, PBW24241067SA, PBW24241069SA 4 00840682152716M1112198-01047271, 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 00840682152709M1112198-01048731, UDI/DI 00840682152709, Serial Numbers: PBW24241087SA, PBW24241086SA, PBW24241085SA, PBW23320042SA, PBW23320041SA, PBW24241084SA, PBW23320035SA 6 00840682152716M1112198-01048740, UDI/DI 00840682152716, Serial Numbers: PBW23482093SA 7 00840682152716M1112198-01052386, UDI/DI 00840682152716, Serial Numbers: PBW23482100SA, PBW24202309SA, PBW24202313SA, PBW24202310SA, PBW24202315SA, PBW24202312SA, PBW24202314SA, PBW24202311SA 8 00840682152716M1112198-01054697, UDI/DI 00840682152716, Serial Numbers: PBW24132200SA 9 00840682152716M1112198-01068942, 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 00840682152716M1112198-01084972, UDI/DI 00840682152716, Serial Numbers: PBW23462025SA, PBW23462038SA, PBW23462039SA, PBW23472051SA, PBW23472049SA, PBW23472050SA, PBW24132204SA, PBW24132203SA, PBW24132205SA, PBW24122189SA, PBW24122190SA 11 00840682152716M1112198-01090848, UDI/DI 00840682152716, Serial Numbers: PBW24122198SA, PBW24122195SA, PBW24122197SA 12 00840682152716M1112198-01093457, UDI/DI 00840682152716, Serial Numbers: PBW24202308SA, PBW24132201SA 13 00840682152709M1112198-01117766, UDI/DI 00840682152709, Serial Numbers: PBW24110390SA 14 00840682152716M1112198-01139893, UDI/DI 00840682152716, Serial Numbers: PBW23242002SA, PBW23242003SA, PBW23242000SA, PBW23242001SA, PBW23512155SA, PBW24062070SA, PBW24172255SA, PBW24172253SA, PBW24172254SA, PBW24172251SA, PBW24172250SA, PBW24212327SA, PBW24212328SA 15 00840682152716M1112198-01156745, UDI/DI 00840682152716, Serial Numbers: PBW24192258SA 16 00840682152716M1112198-01167230, UDI/DI 00840682152716, Serial Numbers: PBW23462035SA, PBW23462036SA, PBW23462040SA, PBW24112159SA 17 00840682152716M1112198-01177090, UDI/DI 00840682152716, Serial Numbers: PBW23482099SA 18 00840682152716M1112198-01183599, UDI/DI 00840682152716, Serial Numbers: PBW23492140SA, PBW23482090SA, PBW23482092SA, PBW23482089SA, PBW23482086SA, PBW23492139SA, PBW23482087SA, PBW23482088SA, PBW23482091SA, PBW23482103SA, PBW23482104SA, PBW23482105SA 19 00840682152716M1112198-01185372, UDI/DI 00840682152716, Serial Numbers: PBW23482079SA, PBW23482081SA, PBW23482082SA, PBW23482083SA, PBW23482078SA 20 00840682152716M1112198-01193801, UDI/DI 00840682152716, Serial Numbers: PBW23502154SA, PBW24172252SA - Amount recalled
- 137 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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