Recall Z-1072-2014 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
GE Healthcare, LLC
GE Healthcare - Giraffe and Panda iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitor
| 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
| K070377 | GIRAFFE AND PANDA WARMER Ohmeda Medical, Jul 11, 2007 |
| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER Ohmeda Medical, Apr 16, 2009 |
| K101804 | GIRAFFE AND PANDA WARMERS Ohmeda Medical, A Division of Datex-Ohmeda, Inc., Jul 21, 2010 |
| K122267 | GIRAFFE AND PANDA WARMERS Ohmeda Medical, A Division of Datex-Ohmeda, Inc., Oct 2, 2012 |