Imrx System V1 and Imrisnv/Imriscardio

• 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-0762-2020 FDA Class II ·initiated 26 Nov 2019

  There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible

510(k) Number

K101813 ↗

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

• Neuro III-Sv Open recall

  Class II

  FDA 510(k) K083137 Active Cleared 16 Dec 2008

See all devices from Imris, Inc. →