- 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)
- 114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 - UDI-DI: 00857534006462, Serial Numbers: 10002996, 10004515, 10007411, 10007376
- Units affected
- 13 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-3034-2026
- 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