FDA recall Z-0541-2020

GE Healthcare, LLC · Class I · device

Product

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.

Distribution

worldwide

Key facts

Status: Terminated
Initiation date: 2019-10-11
Report date: 2019-12-11
Termination date: 2024-08-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0541-2020