Recalls / —
—#177149
Product
Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
- FDA product code
- FMT — Warmer, Infant Radiant
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K152809
- Affected lot / code info
- Giraffe Incubator Carestation, Model Numbers:2082844-002-XXXXXX 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 #177149. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.