FDAClass IIJuly 12, 2023

Beside panel FRU recall

Beside panel FRU (Field Replacement Units) Kits

Why was Beside panel FRU recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Beside panel FRU (Field Replacement Units) Kits
Recalling firm
DATEX--OHMEDA, INC.
Quantity
18
Distribution
Worldwide distribution.
Recall date
July 12, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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