GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-0538-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Giraffe OmniBed infant warmer

Product Classification:

Class I

Date Initiated: October 11, 2019

Date Posted: December 11, 2019

Recall Number: Z-0538-2020

Event ID: 84077

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.

Status: Terminated

Product Quantity: 23,693 units

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.

Distribution Pattern:

worldwide

Voluntary or Mandated:

Voluntary: Firm initiated