Siemens MAGNETOM MRI Systems Recalled for Quench Line Installation Errors
Siemens is recalling MAGNETOM MRI systems due to potential quench line installation errors that could cause oxygen displacement or cold burns.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (oxygen displacement and cold burns) where specific injury reports are not stated in the source text, fitting the High severity criteria for theoretical or unreported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling MAGNETOM systems, which are magnetic resonance diagnostic devices (MRDD). The recall involves 3,752 units distributed nationwide, including the District of Columbia, Puerto Rico, the Virgin Islands, and Bermuda. The affected units were distributed since 1991.
The recall is due to a possible installation error in the quench lines of the superconducting magnets. These lines are designed to vent helium gas in the rare event of a magnet quench. If the quench line is restricted, obstructed, or improperly installed, the helium gas may be blown directly into the magnet room or other areas.
This malfunction could lead to the displacement of oxygen, cause cold burns, and pose a risk to users, patients, or others in the vicinity. Facilities using these devices should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the installation issue.
The recalled product
- Product
- MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 3,752
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 (1)
- all units distributed since 1991
Distribution
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