—#177148

Product

Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer

FDA product code: FMT — Warmer, Infant Radiant
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K152814
Affected lot / code info: Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX Updated 6/3/2021 - All model numbers and units are affected.

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: worldwide

Timeline

Recall initiated: 2019-10-11
Posted by FDA: 2019-12-03
Terminated: 2024-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177148. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.