Regulatory status

as of 29 Oct 2026

Recall ongoing. 4 ongoing FDA recalls name this device. See recalls

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK083137	Date16 Dec 2008Cleared	StatusActive

Coverage

1 jurisdiction

United States — FDA 510(k) Active

6 recalls · 4 ongoing · FDA

4 recalls, same reason
- Ongoing Z-0164-2026 FDA Class I initiated 30 Sep 2025
- Ongoing Z-0163-2026 FDA Class I initiated 30 Sep 2025
- Ongoing Z-0161-2026 FDA Class I initiated 30 Sep 2025
- Ongoing Z-0162-2026 FDA Class I initiated 30 Sep 2025
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Terminated Z-1098-2016 FDA Class II initiated 10 Feb 2016
Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
- Terminated Z-0428-2013 FDA Class II initiated 19 Oct 2012
IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.

510(k)