Recall Z-0912-2014 ยท FMT Warmer, Infant Radiant
GE Healthcare
Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
| Date | Feb 3, 2014 (initiated Dec 12, 2013) |
| Status | Terminated |
| Reason | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. |
| Root cause | Process control |
| Action | GE Healthcare notified end users with a letter flagged as Urgent Medical Device Correction letter on 12/12/2013. The notification advised that GE Healthcare has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. The firm advised that accounts ensure that all potential users in their facility are made aware of this safety notification and the recommended actions described in the notification: 1. Perform blender accuracy check as outlined in Section 2.5-2.5.1 of the Service Manual to verify that the O2 concentration set |
| Quantity | 1970 units |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatem |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123309 | GIRAFFE AND PANDA WARMERS Ohmeda Medical, Feb 5, 2013 |