GE Healthcare recalls certain Panda iRES Warmers due to incomplete electrical safety testing during manufacturing, potentially causing leakage current exceeding safety limits.
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.
GE Healthcare is recalling specific models of Panda iRES Warmers because incomplete electrical safety testing during manufacturing may cause leakage current to exceed safety limits. This could pose a risk of electrical shock to users.
The warmers were manufactured without complete electrical safety testing, which could lead to leakage current exceeding IEC 60601 safety limits. However, the devices include multiple electrical safety protections designed to prevent electrical shock.
Healthcare providers using neonatal radiant warmers for premature infants. The risk is low as the warmers have multiple safety features.
Check for model numbers M1112198-01045518 through M1112198-01274059 on the product label. Also look for serial numbers starting with PBW followed by numbers and SA.
Look for model numbers M1112198-01045518 through M1112198-01274059 or serial numbers starting with PBW followed by numbers and SA.
GE Healthcare has found that incomplete electrical safety testing during manufacturing may cause leakage current to exceed IEC 60601 safety limits.
The recall record does not mention any remedy or fix for this issue.
Check for model numbers M1112198-01045518 through M1112198-01274059 on the product label or serial numbers starting with PBW followed by numbers and SA.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3081-2024 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-3081-2024 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
