Imri 1.5T and Imri 3T S

• 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-1645-2018 FDA Class II ·initiated 4 Apr 2018

  The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.

• • 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.

510(k) Number

K133692 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• SYMBIS Surgical System

  Class II

  FDA 510(k) K143420 Active Cleared 30 Oct 2015

• HFD100 Rocker Arm Accessory

  Class II

  FDA 510(k) K141950 Active Cleared 4 Sep 2014

• Neuro II-Se, Models or-Mb-Dr and or-Dr

  Class II

  FDA 510(k) K061916 Active Cleared 11 Aug 2006

• Ict

  Class II

  FDA 510(k) K130224 Active Cleared 18 Jul 2013

• Imrx

  Class II

  FDA 510(k) K091166 Active Cleared 2 Sep 2009

• Imrx System V1 and Imrisnv/Imriscardio Open recall

  Class II

  FDA 510(k) K101813 Active Cleared 5 Oct 2010

See all devices from Imris, Inc. →