Giraffe OmniBed infant warmer recallZ-0538-2020 · GE Healthcare, LLC · initiated Oct 11, 2019
Class I Terminated All recalls posted in December 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0538-2020
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Oct 11, 2019
- Posted by the FDA
- Dec 3, 2019
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 23,693 units
- Product code
- FMT
- FDA submissions
- K101788, K020543
- Distribution
- worldwide
Product description
Giraffe OmniBed infant warmer
Code information (models, lots, serial numbers)
Model Numbers: 6650-0XXX-XXX 2074920-00X-XXXXXX M1050205 M1136116 M1136215 M1139253 M1145528 M1145529 M1146094 M1149051 M1149079 M1149081 M1149087 M1149108 M1161324 M1161328 M1161338 M1162796 M1206147 M1235957 Updated 6/3/2021 - All model numbers and units are affected.
Other devices under the same FDA submission
1 device cleared under K101788, K020543 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Giraffe OmniBed Carestation CS1Datex-Ohmeda, Inc. · INCUBATOR, NEONATAL2 recalls217 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 84077).
- Z-0539-2020 · TerminatedGiraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer
- Z-0540-2020 · TerminatedGiraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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