Reported Jul 12, 2023 · Ongoing
Beside panel FRU (Field Replacement Units) Kits
Datex--Ohmeda, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DATEX--OHMEDA, INC. · 9900 W Innovation Dr · Wauwatosa, WI · 53226-4856
Is this the product you have?
- Beside panel FRU (Field Replacement Units) Kits
- Lot codes and dates
- Models5865384-01 to 5865384-34, 5865385-01 to 5865385-34, 5865386-01 to 5865386-34 and 5865387-01 to 5865387-34
- Amount recalled
- 18
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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