- Recalling firm
- IMRIS Imaging Inc
- Reason for recall
- The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
- Affected products (lot / model / serial)
- 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997
- Units affected
- 6 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
- Firm location
- Chaska, MN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3033-2026
- Recall initiated
- August 6, 2026
- FDA classification date
- August 26, 2026
- FDA report date
- September 2, 2026
- FDA event ID
- 99596
- Last updated on HTM Vibe
- September 8, 2026