Siemens Medical Solutions USA recalled 23 Biograph mMR PET-MRI systems worldwide after detecting an ice blockage in the magnet venting system. In a magnet quench, helium gas may not escape through vent paths, risking rupture of the helium containment and a leak into the scanning room. Hospitals and providers must stop using the device immediately and follow the manufacturer’s recall instructions.
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
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The Biograph mMR is a PET-MRI system used by hospitals to perform combined metabolic and anatomic imaging. It plays a critical role in oncology, neurology, and cardiology diagnostics.
Ice blockage in the magnet venting system may prevent helium gas from escaping during a quench. This can raise pressure and rupture the helium containment, potentially releasing helium into the scanning room.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals must halt use of affected units. Depending on remediation timing, patient imaging schedules could be disrupted and safety precautions must be strictly followed.
Model numbers and UDIs are on the device label and in the recall documentation provided to facilities.
Remediation timelines vary by facility; typical service or replacement processing may take weeks.
Keep the recall notification, serial numbers, UDIs, photos of the device label, and all correspondence with Siemens for records.
Model Number: 10433372. UDI numbers include (01)04056869006741(21)151032 and additional UDIs: (01)04056869006741(21)151057, (01)04056869006741(21)510535, (01)04056869006741(21)151034, (01)04056869006741(21)51003, (01)04056869006741(21)151021, (01)04056869006741(21)51055, (01)04056869006741(21)151013, (01)04056869006741(21)51064, (01)04056869006741(21)151044, (01)04056869006741(21)51038, (01)04056869245188(21)51006, (01)04056869006741(21)51030, (01)04056869006741(21)151004, (01)04056869006741(21)51022, (01)04056869006741(21)151049, (01)04056869006741(21)151045, (01)04056869006741(21)51032, (01)
No injuries or incidents have been reported.
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