FDA recall Z-2102-2023

DATEX--OHMEDA, INC. · Class II · device

Product

Beside panel FRU (Field Replacement Units) Kits

Reason for recall

GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices

Distribution

Worldwide distribution.

Key facts

Status: Ongoing
Initiation date: 2023-05-19
Report date: 2023-07-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wauwatosa, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2102-2023