Z-0541-2020Class I

Giraffe Incubator infant warmer

Name: Z-0541-2020 Giraffe Incubator infant warmer
Creator: GE Healthcare, LLC
Published: 2019-10-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-10-11 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Giraffe Incubator infant warmer on 2019-10-11. FDA classified it as Class I and gives the reason as "Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0541-2020
Classification: Class I
Status: Terminated
Initiated: 2019-10-11
Posted: 2019-12-03
Terminated: 2024-08-15
Recalling firm: GE Healthcare
Product: Giraffe Incubator infant warmer
Product code: FMT Warmer, Infant Radiant
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 19425 units
Distribution: worldwide
Product codes and lots: Model Numbers: 6651-XXXX-XXX 2074921-00X-XXXXXX M1050206 M1050207 M1136120 M1136222 M1136226 M1138367 M1145526 M1145527 M1146091 M1146092 M1148634 M1161351 M1161353 M1161357 M1206149 M1235958 Updated 6/3/2021 - All model numbers and units are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0541-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0538-2020	Class I	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-03
Z-0539-2020	Class I	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-03
Z-0540-2020	Class I	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-03
Z-0541-2020	Class I	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-03

Product code FMT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)