Recall Z-2358-2026 ยท FMT Warmer, Infant Radiant
Datex-Ohmeda Inc
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
| Date | Jun 18, 2026 (initiated May 8, 2026) |
| Status | Open, Classified |
| Reason | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient. |
| Root cause | Process control |
| Action | Firm began notifying customers on 5/8/2026 via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were instructed to identify affected devices by following instructions provided in the letter. Devices with affected blenders should be removed from patient use, and the customer should contact a GE HealthCare Service Representative. |
| Quantity | 550 (367 US; 183 OUS) |
| Distribution | Pending |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201628 | Panda iRes Warmer, Giraffe Warmer GE Healthcare, Feb 12, 2021 |