Recall Z-0748-2013 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
GE Healthcare, LLC
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
| Date | Feb 8, 2013 (initiated Oct 15, 2012) |
| Status | Terminated |
| Reason | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. |
| Root cause | Employee error |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated October 15, 2012, with a return receipt to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer along with the product correction. Required Action for Users: It is recommended that a qualified biomedical technician or respiratory therapist identify the affected resuscitation system and locate the air and oxygen fittings and labels at the back of the unit. With the table provided, identify the appropriate fitting for their country and location and verify the air fi |
| Quantity | 276 units total, 109 of those nationwide. |
| Distribution | Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX, VT, WA, WI and WV; and the countries of Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerla |
| 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 |