MAGNETOM Cima.X systems recalled over ice blockage in helium venting system
Siemens is recalling 22 MAGNETOM Cima.X (DE) systems because an ice blockage in the magnet venting system could prevent helium escaping 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 Critical tier.
Plain-English summary
MAGNETOM Cima.X (DE) systems, model number 11647158, are being recalled because an ice blockage may form, or may already exist, within the magnet venting system.
In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. That pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
The recall covers 22 units, distributed worldwide including nationwide in the United States. The FDA has classified the recall as Class I.
Operating sites should follow the manufacturer's instructions for inspection and correction of the venting system before further use.
The recalled product
- Product
- MAGNETOM Cima.X (DE). Model Number: 11647158.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — MRI system
- Hazard
- helium-leak
- pressure-buildup
- venting-failure
- quench
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 (20)
- Model Number: 11647158. UDI Numbers: (01)04056869975221(21)213029
- (01)04056869975221(21)213006
- (01)04056869975221(21)213062
- (01)04056869975221(21)213043
- (01)04056869975221(21)213041
- (01)04056869975221(21)213034
- (01)04056869975221(21)213035
- (01)04056869975221(21)213028
- (01)04056869975221(21)213031
- (01)04056869975221(21)213018
- (01)04056869975221(21)213061
- (01)04056869975221(21)213005
- (01)04056869975221(21)213021
- (01)04056869975221(21)213022
- (01)04056869975221(21)213056
- (01)04056869975221(21)213030
- (01)04056869975221(21)213039
- (01)04056869975221(21)213025
- (01)04056869975221(21)213063
- (01)04056869975221(21)213057
Distribution
Distributed nationwide across the United States.
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