GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M11121
FDA device recall Z-3081-2024 · posted 2024-09-20 · Open, Classified
Recall details
- Recalling firm
- Wipro GE Healthcare Private Ltd.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FMT
- Quantity affected
- 137 units
- Distribution
- US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom.
- Date initiated
- 2024-08-09
- Date posted
- 2024-09-20
- Location
- Bengaluru, India
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Panda iRes Warmer, Giraffe Warmer (K201628) | GE Healthcare | 2021-02-12 |