GE Giraffe Warmer Recalled for Incomplete Electrical Safety Testing
Wipro GE Healthcare is recalling specific GE Giraffe Warmers because incomplete electrical safety testing during manufacturing may allow leakage current to exceed safety limits.
What this means for you
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: The recall involves a medical device with a potential electrical hazard (leakage current) where no injuries or illnesses have been reported, fitting the rubric for risk-of-harm products without reported injury.
Plain-English summary
Wipro GE Healthcare is recalling specific units of the GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. The recall affects a single unit with Serial Number GBW24230381SA. These infant radiant warmers are used to provide controlled infrared heat to neonates who cannot regulate their own body temperature.
The recall was initiated because complete electrical safety testing was not conducted during the manufacturing process for these devices. Although the product design includes multiple electrical safety protections, the incomplete testing creates a potential for leakage current to exceed IEC 60601 limits.
The affected device was distributed in the US and Australia, Denmark, France, Germany, Ireland, Italy, New Zealand, Poland, Portugal, Slovenia, Spain, Switzerland, the United Arab Emirates, and the United Kingdom. Users should contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. 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 t
- Manufacturer
- Wipro GE Healthcare Private Ltd.
- Affected units
- 1
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 (1)
- Serial Number GBW24230381SA
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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