GE Healthcare, LLC Giraffe Incubator infant warmer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Giraffe Incubator infant warmer
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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.
GE Healthcare, LLC is recalling Giraffe Incubator infant warmer due to Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed wit. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026