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Recall Observatory FDA recall evidence

Device product

Beside panel FRU (Field Replacement Units) Kits

Z-2102-2023

May 19, 2023

Class II

Product summary

Firm
DATEX--OHMEDA, INC.
Event
Event 92454
Status
Ongoing
Classification
Class II
Quantity
18
Official record key
device-enforcement:Z-2102-2023

Official wording

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

Code information: Models: 5865384-01 to 5865384-34, 5865385-01 to 5865385-34, 5865386-01 to 5865386-34 and 5865387-01 to 5865387-34

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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