Wipro GE Healthcare Private Ltd.: Medical Device Recall in 2024 - (Recall #: Z-3080-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 9, 2024

Date Posted: October 2, 2024

Recall Number: Z-3080-2024

Event ID: 95216

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.

Status: Ongoing

Product Quantity: 1

Code Information:

Serial Number GBW24230381SA

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated