Z-2477-2026Class II

Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

Name: Z-2477-2026 Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Creator: GE Medical Systems, LLC
Published: 2026-05-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2026-05-01 / Open, Classified / root cause: design

FDA source

GE Medical Systems, LLC began a recall of Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500 on 2026-05-01. FDA classified it as Class II and gives the reason as "GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2477-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-01
Posted: 2026-06-17
Recalling firm: GE Healthcare
Product: Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Product code: FMZ Incubator, Neonatal
Reason for recall: GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
Root cause tag: design
FDA root cause: Component design/selection
Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 5/1/26 was sent to customers. Actions to be taken by Customer/User You may continue to use your device after performing the pre-use checkout in accordance with the Giraffe OmniBed Carestation User Manual (Chapter 6 Pre-Use Checkout). During the pre-use checkout described in the product User Manual, visually inspect the device for any damaged or missing components. This includes verifying that the canopy soffit is properly secured and that all six fasteners are present and fully engaged. If you observe damage, missing fasteners, or improper soffit attachment during the pre-use checkout, please remove the device from clinical use and contact GE HealthCare Service. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please complete and return the attached acknowledgement form electronically via FMI 32101 Digital CRF or print, fill out manually, scan, and email to [email protected]. Please retain this document for your records. Product Correction GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. Contact Information If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact GE HealthCare per the contact information above.
Quantity in commerce: 265 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2477-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2475-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2476-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2477-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17

Product code FMZ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)