BIOGRAPH One scanner recalled over ice blockage in magnet venting system
Siemens is recalling one BIOGRAPH One (DE) system 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
The BIOGRAPH One (DE) system, model number 11689172, is 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 one unit, serial number 238008, from a worldwide distribution that includes the United States. The FDA has classified the recall as Class I.
The operating site should follow the manufacturer's instructions for inspection and correction of the venting system before further use.
The recalled product
- Product
- BIOGRAPH One (DE). Model Number: 11689172.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Imaging system
- Affected units
- 1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Siemens Medical Solutions USA, 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.
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