Giraffe OmniBed infant warmer
FDA device recall Z-0538-2020 · posted 2019-12-03 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
- Action taken
- The firm disseminated its notices by letter beginning on 10/11/2019. The notices identified the following safety issues: - The bedside panels of Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation can be upright and look closed but not be latched. - The portholes also can look closed when not latched. - If a canopy cover is used, it can hold the bedside panel or porthole door closed without being latched. The product may continue to be used following specific safety instructions outlined in the notice. On/about 11/8/2019, the firm issued an "Amended - Urgent Medical Device Recall" letter that supplemented the previous notification to provide additional safety instructions and materials (poster regarding risk of patient fall, user manual addendum, and labeling, including safety labels). Update 6/3/2021: In the event a new consignee was identified, GE Healthcare has sent the original letter.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FMT
- Quantity affected
- 23,693 units
- Distribution
- worldwide
- Date initiated
- 2019-10-11
- Date posted
- 2019-12-03
- Date terminated
- 2024-08-15
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GIRAFFE OMNIBED (K101788) | Ohmeda Medical | 2010-07-21 |
| OHMEDA MEDICAL GIRAFFE OMNIBED (K020543) | Ohmeda Medical | 2002-05-09 |