GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-0541-2020)

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 Incubator infant warmer

Product Classification:

Class I

Date Initiated: October 11, 2019

Date Posted: December 11, 2019

Recall Number: Z-0541-2020

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: 19425 units

Code Information:

Model Numbers: 6651-XXXX-XXX 2074921-00X-XXXXXX M1050206 M1050207 M1136120 M1136222 M1136226 M1138367 M1145526 M1145527 M1146091 M1146092 M1148634 M1161351 M1161353 M1161357 M1206149 M1235958 Updated 6/3/2021 - All model numbers and units are affected.

Distribution Pattern:

worldwide

Voluntary or Mandated:

Voluntary: Firm initiated