Giraffe OmniBed infant warmer
FDA Recall Z-0538-2020 · Posted 2019-12-03
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeFMT
Date Initiated2019-10-11
Date Terminated2024-08-15
Product Quantity23,693 units
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.
Firm Action
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
Distribution Pattern
worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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