Recall
FDAHealthMay 1, 2026

GE Medical Systems, LLC — Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
May 1, 2026

Worldwide - US Nationwide distribution.

What's affected?

Product
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Lot code
Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 265 units.

View original FDA notice →

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