- Recalling firm
- GE Medical Systems, LLC
- 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.
- Affected products (lot / model / serial)
- Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382
- Units affected
- 265 units
- Distribution pattern
- Worldwide - US Nationwide distribution.
- Firm location
- Waukesha, WI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2477-2026
- Recall initiated
- May 1, 2026
- FDA classification date
- June 17, 2026
- FDA report date
- June 24, 2026
- FDA event ID
- 98986
- Last updated on HTM Vibe
- July 23, 2026