Z-2102-2023 Class II Ongoing
FDA device recall Z-2102-2023 was initiated by DATEX--OHMEDA, INC. on May 19, 2023 and is designated Class II. 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 OmniB… The recall status is ongoing. Affected quantity: 18.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2023
- Initiation Date
- May 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18
Product Description
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 Pattern
Worldwide distribution.
Code Information
Models: 5865384-01 to 5865384-34, 5865385-01 to 5865385-34, 5865386-01 to 5865386-34 and 5865387-01 to 5865387-34