Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road
FDA device recall Z-1051-2013 · posted 2013-04-05 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure.
- Action taken
- GE Healthcare sent an "Urgent Medical Device Correction" letter, dated January 8, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were given the safety issue and instructions for continued use of the Giraffe OmniBed and Incubators, as well as given the affected product details. GE Healthcare will correct all affected Giraffe Incubators and Giraffe OmniBeds at no cost, and will contact customers to arrange for this correction. If customers have any questions or concerns regarding this notification, please call: United States: 1-800-345-2700. For other countries, please contact your local GE Healthcare Service Representative.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FMZ
- Quantity affected
- 679 units
- Distribution
- Worldwide Distribution -- USA in the states of AR ,CA, CO, DC, FL, GA, HI, ID, IL, IN, KS, MA, MD, MI, MO, MS, NC, NE, NJ, NY, NV, OH, PA, TN, TX, VA, WA, WI, and WV, and the countries of Arab Emirate
- Date initiated
- 2013-01-08
- Date posted
- 2013-04-05
- Date terminated
- 2013-07-10
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GIRAFFE INCUBATOR (K101778) | Ohmeda Medical | 2010-07-21 |
| GIRAFFE OMNIBED (K101788) | Ohmeda Medical | 2010-07-21 |