CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report
Giraffe OmniBed Field Replaceable Unit (FRU) recalled
GE Medical Systems is recalling Giraffe OmniBed Field Replaceable Unit (FRU), distributed nationwide in the US. The recall was initiated on 1 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2477-2026
- FDA event ID
- 98986
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 May 2026
- FDA classified
- 17 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 May 2026 | Recall initiated by company | |
| 17 Jun 2026 | Classified by FDA | +47 days |
| 24 Jun 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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