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Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers… recallZ-2477-2026 · GE Medical Systems, LLC · initiated May 1, 2026

Class II Open, Classified All recalls posted in June 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-2477-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
May 1, 2026
Posted by the FDA
Jun 17, 2026
Recalling firm
GE Medical Systems, LLC
Quantity
265 units
Product code
FMZ
FDA submissions
K020543, K101788, K152814, K213551
Distribution
Worldwide - US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382

Other devices under the same FDA submission

1 device cleared under K020543, K101788, K152814, K213551 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98986).

Sources and updates

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