Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094
Summary
The FDA issued a Class II for Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, by DATEX--OHMEDA, INC.. 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 north.
Details
Source
Device Recall
External ID
Z-2101-2023
Action Date
2023-07-12
Status
Ongoing
Category
device
Product Description
Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901, 6650-0082-902, 6650-0061-902, 6650-0131-902, 6650-0034-902, 6650-0104-902, 6650-0066-902, 6650-0042-902, 6650-0143-901, 6650-0148-902, 6650-0152-901, 6650-0107-902, 6650-0136-902, 6650-0060-902, 6650-0056-902, 6650-0043-902. Labeled as OMNIBED ENG EBASE S-HUMID, GIRAFFE OMNIBED, GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, OMNIBED SW EBASE S-HUMID, Giraffe OmniBed Legacy, OMNIBED FR EBASE S-HUMID, OMNIBED GR EBASE S-HUMID, OMNIBED SP EBASE S-HUMID, ASSY-LAU, OMNIBED ENG EBASE S-HUMI D, Finished good - Make, OBSOLETE-OMNIBED UK EBASE S-HUMID, OMNIBED UK EBASE S-HUMID. Incubator, Neonatal
Lot/Code Info: All Lot/Serial Numbers
Quantity Affected: 3,053 units
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
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-19
Company
Wauwatosa, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 287 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DATEX--OHMEDA, INC. has 29 FDA actions in our database, including 24 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DATEX--OHMEDA, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DATEX--OHMEDA, INC. have FDA actions?
DATEX--OHMEDA, INC. has 29 FDA actions in our database, including 24 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2101-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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