Recall Z-0916-2014 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
GE Healthcare
Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants
| 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 | 375 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
| K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM Ohmeda Medical, Apr 20, 2007 |