Siemens Medical Solutions USA recalled one MAMMOMAT Fusion operator table on October 24, 2025. The table was sold with a bus-installation kit but is intended for stationary use only. This recall affects distribution in Arkansas, California, New York, and internationally in Australia, Canada, and India.
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 recalled product is the MAMMOMAT Fusion operator table, Model Number: 10140000, UDI-DI: 04056869009063, System Serial Number: 10559. It was distributed worldwide and specifically in the US states of Arkansas, California, and New York.
The operator table was sold with a bus-installation kit, posing a risk since it is designed solely for stationary operation. Using the table inappropriately could lead to equipment malfunction or injury.
There have been no reported injuries or incidents related to this recall. The device was classified as Class II, indicating a moderate to high risk.
Patients and healthcare providers should stop using the device immediately. Follow the manufacturer’s recall instructions and contact Siemens Medical Solutions USA, Inc for further guidance.
For more information, contact Siemens Medical Solutions USA at the number provided in the recall letter. Visit the FDA's official recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0879-2026.
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