MAGNETOM Spectra MRI systems recalled over helium venting ice blockage
Siemens is recalling three MAGNETOM Spectra MRI 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 Spectra MRI systems, model number 10837643, and MAGNETOM Spectra (CN), model number 10655588, 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 three units, including serial number 72030, 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 Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — MRI system
- Affected units
- 3
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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