One unit of the Siemens MAMMOMAT Fusion operator table is recalled after being sold with a bus-installation kit. The device is not intended for bus installations and is designed for stationary operation. Health care providers should stop using the device immediately and follow the manufacturer’s recall instructions.
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
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 MAMMOMAT Fusion is a stationary mammography imaging table used in clinical settings. This recall concerns the operator table being sold with a bus-installation kit, which is not intended or released for bus installations.
Using a stationary table with a bus-installation kit creates a mismatch in installation and operation, potentially compromising device performance or patient safety.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics may need to separate the operator table from bus installations, pause related imaging workflows, and coordinate with Siemens for proper remediation.
Model number and UDI-DI are on the device label. System serial number is on the equipment card or label.
Remedies will be provided per recall instructions. Timeline depends on manufacturer process.
Keep a copy of recall notices, take photos of device labels (model, UDI, serial number), document communications with the manufacturer and hospital risk management.
Model Number: 10140000. UDI-DI: 04056869009063. System Serial Numbers: 10559. Sold Worldwide. US distribution in AR, CA, NY. Other countries: Australia, Canada, India.
No injuries or incidents have been reported.
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