Recall Z-2102-2023— DATEX--OHMEDA, INC.
Class II · Ongoing
Class II FDA medical device recall by DATEX--OHMEDA, INC., initiated 2023-05-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Beside panel FRU (Field Replacement Units) Kits. Reason: 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.
- Recalling firm
- DATEX--OHMEDA, INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-19
- Firm location
- Wauwatosa, WI, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.