InVision operating suite recalled over ice blockage in magnet venting paths
IMRIS is recalling the InVision 3T Operating Suite because an ice blockage in the Siemens 3 Tesla Vida magnet's venting system could rupture the helium containment system during a quench.
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, InVision 3T Operating Suite, 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 00857534006806 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, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
- Manufacturer
- IMPRIS Imaging Inc
- Category
- Medical Device — MRI system
- Hazard
- helium-release
- quench
- pressure-rupture
- class-i
- ice-blockage
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 00857534006806
Distribution
Distributed nationwide across the United States.
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