Z-2102-2023Class II

Beside panel FRU (Field Replacement Units) Kits

Name: Z-2102-2023 Beside panel FRU (Field Replacement Units) Kits
Creator: Datex--Ohmeda, Inc.
Published: 2023-05-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2023-05-19 / Open, Classified / root cause: manufacturing process

FDA source

DATEX--OHMEDA, INC. began a recall of Beside panel FRU (Field Replacement Units) Kits on 2023-05-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2102-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-19
Posted: 2023-07-06
Recalling firm: GE Healthcare
Product: Beside panel FRU (Field Replacement Units) Kits
Product code: FMZ Incubator, Neonatal
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees beginning on 05/19/2023 by mail. The notice explained the problem, risk, and requeested the following: Actions to be taken by Customer/User: Inspect the device bedside panels; if the device has the correct latches, continue to use the device. If the device does not have the correct latches, quarantine the device. Inspect any field replaceable bedside panel stock and quarantine for the affected product. GE Healthcare will replace affected latches.
Quantity in commerce: 18
Distribution: Worldwide distribution.
Product codes and lots: Models: 5865384-01 to 5865384-34, 5865385-01 to 5865385-34, 5865386-01 to 5865386-34 and 5865387-01 to 5865387-34

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2102-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2100-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06
Z-2101-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06
Z-2102-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06

Product code FMZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)