Recall Z-2323-2017 ยท FMT Warmer, Infant Radiant
GE Healthcare, LLC
Infant Warmer System (IWS)
| Date | May 19, 2017 (initiated May 5, 2017) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue. |
| Root cause | Under Investigation by firm |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated May 5, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Product Correction : Attached to this letter, we provide instructions as part of a Service Manual Addendum on how to correct the issue. Please add this new Addendum to the Service Manual of your device(s) and train the affected users accordingly. Please acknowledge that you have received this letter and that you understand that an action needs to be taken on your part to correct th |
| Quantity | 34986 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K840858 | OHIO 3300 INFANT WARMER SYSTEM Ohio Medical Products, Mar 23, 1984 |
| K851449 | OHMEDA 5000 INFANT WARMER SYSTEM Ohmeda Medical, Jun 7, 1985 |
| K884160 | OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM Ohmeda Medical, Nov 21, 1988 |
| K921766 | OHIO INFANT WARMER SYSTEM Ohmeda Medical, Apr 23, 1993 |
| K963058 | INFANT WARMER SYSTEM Ohmeda Medical, Oct 1, 1996 |