GE Panda iRES infant warmer electrical safety testing incomplete
GE Panda iRES infant warmers may have incomplete electrical safety testing that could cause leakage current to exceed safe limits. The company is recalling 137 units distributed in the US and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or hospitalizations. The hazard is theoretical—potential electrical leakage in a device used with vulnerable neonates—qualifying as a risk-of-harm product without reported injury, per the rubric.
Plain-English summary
GE HealthCare is recalling certain GE Panda iRES infant radiant warmers due to incomplete electrical safety testing during manufacturing. Although the devices are designed with multiple electrical safety protections, the incomplete testing means leakage current could potentially exceed IEC 60601 safety limits.
The infant warmers are used in hospital settings to provide controlled infrared heat to newborns. A total of 137 units distributed in the United States and internationally are affected, including units in Australia, Denmark, France, Germany, Ireland, Italy, New Zealand, Poland, Portugal, Slovenia, Spain, Switzerland, the United Arab Emirates, and the United Kingdom.
Healthcare providers using affected units should stop use immediately and contact the manufacturer, Wipro GE Healthcare Private Ltd., for corrective instructions. Affected model and serial numbers are available through the FDA recall notice.
The recalled product
- 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)…
- Manufacturer
- Wipro GE Healthcare Private Ltd.
- Category
- Medical Device — Infant Warmer
- Affected units
- 137
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) M1112198-01045518
- UDI/DI 00840682152709
- Serial Numbers: PBW23420278SA
- PBW23390175SA
- PBW24241071SA
- PBW24241072SA
- PBW24241075SA
- PBW23340090SA
- 2) M1112198-01045579
- Serial Numbers: PBW24241078SA
- PBW24241079SA
- PBW24241063SA
- PBW24241076SA
- 3) M1112198-01047148
- Serial Numbers: PBW24241068SA
- PBW24241070SA
- PBW24241065SA
- PBW24241064SA
- PBW24241066SA
- PBW24241067SA
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Wipro GE Healthcare Private Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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