# FDA recall Z-3080-2024

> **Wipro GE Healthcare Private Ltd.** · Class II · device recall initiated 2024-08-09.

## 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 to the external environment or to provide a controlled open environment.

## 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.

## Distribution

US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-3080-2024
- **Recalling firm:** Wipro GE Healthcare Private Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-09
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bengaluru, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3080-2024

## Citation

> AI Analytics. FDA recall Z-3080-2024. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-3080-2024. Source: US FDA. Licensed CC0.

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