MAMMOMAT Inspiration (Siemens) – Incorrect Table Installation (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MAMMOMAT Inspiration;
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model Number: 10140000, UDI-DI: 04056869009063, System Serial Numbers: 6734, 6694, 10121, 10309, 10336, 10342
Products Sold
Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 6734, 6694, 10121, 10309, 10336, 10342;
Siemens Medical Solutions USA, Inc is recalling MAMMOMAT Inspiration; due to 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 b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On October 24, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: Please ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your personnel accordingly. Please ensure that this safety advisory is retained in your product related records appropriately. Please keep this information until the corrective measures have been finalized. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification. If this device/equipment is no longer in your possession, please forward this Customer Safety Advisory Notice to the new owner of this device. If applicable, please inform us about the new owner of the device.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026