Recall Z-3081-2024 ยท FMT Warmer, Infant Radiant
Wipro GE Healthcare Private Ltd.
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) M1112198-01084972; 11) M1112198-01090848; 12) M1112198-01093457; 13) M1112198-01117766; 14) M1112198-01139893; 15) M1112198-01156745; 16
| Date | Sep 20, 2024 (initiated Aug 9, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 08/09/2024 by letter disseminated through a traceable means. The notice explained the safety issue and the potential for adverse impact to user or patient. The notice also provided information for the safe operation of the device until GE Healthcare is able to inspect and test the units. A GE Healthcare representative will contact the consignee to arrange for the correction. Questions: Contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 137 units |
| Distribution | US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201628 | Panda iRes Warmer, Giraffe Warmer GE Healthcare, Feb 12, 2021 |