Class I — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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. |
| Product | Giraffe OmniBed® and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer. |
| Quantity | 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 Emirates, Albania, Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czech., Denmark, Ecuador, Estonia, Finland, France, Germany, Hungary, Italy ,Korea, Kurdistan, Lebanon, Macedonia, Malaysia, Me… |
| Initiated | 2013-01-08 |
| Classified | 2013-04-05 |
| Terminated | 2013-07-10 |
| Recall number | Z-1051-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — GE Healthcare, LLC (Z-1051-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64189/
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