Siemens Medical Solutions USA recalled the MAGNETOM Connectom.X. MRI Scanner on August 28, 2025. The recall affects one unit worldwide due to a potential helium leak risk. Users must stop using the device immediately as it poses a high hazard level.
There is a potential for an ice blockage to form or currently 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. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions. Notification method: Letter
The recalled product is the MAGNETOM Connectom.X. with model number 11371480. It was distributed worldwide, including the United States and several countries, but only one unit was affected.
This MRI scanner may suffer from an ice blockage in the magnet venting system. If a quench occurs, helium gas may not escape properly, leading to a dangerous pressure build-up and potential rupture of the helium containment system.
No injuries or incidents have been reported related to this recall. The absence of incidents does not diminish the identified high hazard risk.
Stop using the MAGNETOM Connectom.X. Contact Siemens Medical Solutions USA or your healthcare provider for further instructions regarding the recall.
For more details, call Siemens Medical Solutions USA at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2657-2025.
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