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IMRIS iMRI 3T V

by Deerfield Imaging, Inc. 510(k)

Active United States Open recall

510(k) K212367

Regulatory status

as of 29 Oct 2026

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212367 Date23 Aug 2021ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

4 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.

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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