Official recall record

IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida

US FDA — Medical Devices · 2025-09-30 · United StatesClass I

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2025-09-30
Country of alert: United States
Alert level: Class I
Alert type: recall
Barcode (EAN/GTIN): 00857534006806
Brand on record: IMPRIS Imaging Inc

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

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ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.