Z-0538-2020 Class I Terminated
FDA device recall Z-0538-2020 was initiated by GE Healthcare, LLC on October 11, 2019 and is designated Class I. 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. The recall status is terminated (terminated August 15, 2024). Affected quantity: 23,693 units.
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.