FDA recall Z-0047-2025

Product

GE Heathcare Giraffe OmniBed; neo natal incubator

Reason for recall

GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-09-03

Report date

2024-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wauwatosa, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0047-2025