Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
IMRIS Operating Suite Recalled by IMPRIS Imaging Inc Due to There is a potential safety issue associated with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact IMPRIS Imaging Inc directly.
Affected Products
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
Quantity: N/A
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About IMPRIS Imaging Inc
IMPRIS Imaging Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report