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U.S. Department of Health and Human Services

Class 2 Device Recall MAMMOMAT

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 Class 2 Device Recall MAMMOMATsee related information
Date Initiated by FirmOctober 24, 2025
Date PostedDecember 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0877-2026
Recall Event ID 97920
510(K)NumberK193166 
Product Classification Full field digital, system, x-ray, mammographic - Product Code MUE
ProductMAMMOMAT Revelation;
Code Information Model Number: 11343300; UDI-DI: 04056869124575; System Serial Numbers: 1296, 10550, 10572, 10606, 10608, 11511, 20140;
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactRebecca Tudor
610-219-4834
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Component design/selection
ActionOn 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.
Quantity in Commerce7 units (3 US, 4 OUS)
DistributionWorldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MUE
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