Recall Z-1071-2014 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
GE Healthcare, LLC
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation
| Date | Feb 25, 2014 (initiated Oct 1, 2013) |
| Status | Terminated |
| Reason | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. |
| Root cause | Component design/selection |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated November 18, 2013, with a return receipt to all affected customers. The letter identified the products, the problem, and safety instructions to be taken by the customer along with the product correction. It is recommended that all potential users in your facility are made aware of this safety notification and the recommended actions. Safety issues described the description and affected product details, safety instructions, photos showing the back of the resuscitation system where the Air and Oxygen fittings are located and an |
| Quantity | 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown |
| Distribution | Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and the countries of Alba |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM Ohmeda Medical, Apr 20, 2007 |