Z-0538-2020 Class I Terminated

Recalled by GE Healthcare, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
December 11, 2019
Initiation Date
October 11, 2019
Termination Date
August 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23,693 units

Product Description

Giraffe OmniBed 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 Pattern

worldwide

Code Information

Model Numbers: 6650-0XXX-XXX 2074920-00X-XXXXXX M1050205 M1136116 M1136215 M1139253 M1145528 M1145529 M1146094 M1149051 M1149079 M1149081 M1149087 M1149108 M1161324 M1161328 M1161338 M1162796 M1206147 M1235957 Updated 6/3/2021 - All model numbers and units are affected.