MRI upgrade recalled over ice blockage in helium venting paths
Siemens Medical Solutions is recalling four MAGNETOM Cima.X Upgrade systems because an ice blockage may form in the magnet's helium venting paths. The FDA has classified it Class I.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 MAGNETOM Cima.X Upgrade, model 11689304, from Siemens Medical Solutions USA, is being recalled.
There is a potential for an ice blockage to form, or to currently exist, within the primary and/or auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system.
The recall covers 4 systems, of which the record lists 1 in the United States and 3 outside it, carrying UDI 04056869975245, serial number 237304. Distribution was to California and internationally to Australia, Germany and Great Britain. The FDA has classified the recall as Class I, its most serious category.
Sites operating an affected system should follow Siemens' instructions.
The recalled product
- Product
- MAGNETOM Cima.X Upgrade. Model Number: 11689304.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — MRI system
Distribution
Distributed in 1 state:
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