Recall Z-0541-2020— GE Healthcare, LLC
Class I · Terminated
Class I FDA medical device recall by GE Healthcare, LLC, initiated 2019-10-11, terminated 2024-08-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Giraffe Incubator infant warmer. Reason: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-10-11
- Terminated
- 2024-08-15
- Firm location
- Waukesha, WI, United States
Product description
Giraffe Incubator infant warmer
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.