GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product
FDA device recall Z-1070-2014 · posted 2014-02-25 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
- Action taken
- 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 appendix of the Affected Product Serial Number Definition and Configurations of Fittings. For questions or concerns regarding this notification, please call the phone number listed below: United States: 1-800-345-2700.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- BTL
- Quantity affected
- 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, O
- Date initiated
- 2013-10-01
- Date posted
- 2014-02-25
- Date terminated
- 2016-07-22
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM (K070210) | Ohmeda Medical | 2007-04-20 |