MRI operating suites recalled over ice blockage in the magnet venting system
IMRIS is recalling the IMRIS iMRI 3T V Operating Suite because an ice blockage in the Siemens 3 Tesla magnet's venting system could rupture the helium containment system during a quench. The FDA classified it Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
The IMRIS Operating Suite, IMRIS iMRI 3T V, containing a Siemens 3 Tesla MRI magnet (vIDA), part number 120823-000, is being recalled.
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 that system and potentially result in a helium leak into the scanning room.
The product carries UDI-DI 00857534006745 and was distributed worldwide, including nationwide in the United States and to Canada, Sweden, Switzerland, Japan, Australia, Qatar and China. The FDA has classified the recall as Class I, its most serious category, used where there is a reasonable probability of serious injury or death.
Sites operating an affected suite should follow the firm's instructions.
The recalled product
- Product
- IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
- Manufacturer
- IMPRIS Imaging Inc
- Category
- Medical Device — MRI system
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- IMRIS Part Number(s): 120823-000
- UDI/DI 00857534006745
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by IMPRIS Imaging Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · IMPRIS Imaging Inc
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Same hazard · helium release
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FDA (Devices) · 2026-01-21
- CriticalMRI upgrade recalled over ice blockage in helium venting paths
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FDA (Devices) · 2021-09-01
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FDA (Devices) · 2021-09-01