Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0161-2026 — IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

U.S. FDA — Device Enforcement · United States · 2025-09-30 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0161-2026
Date of alert
2025-09-30
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
IMPRIS Imaging Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00857534006189
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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