Z-0879-2026Class II

MAMMOMAT Fusion

Name: Z-0879-2026 MAMMOMAT Fusion
Creator: Siemens Medical Solutions USA, Inc
Published: 2025-10-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2025-10-24 / Open, Classified / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of MAMMOMAT Fusion on 2025-10-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0879-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-24
Posted: 2025-12-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MAMMOMAT Fusion;
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 1 unit (OUS only)
Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
Product codes and lots: Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 10559;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0879-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0877-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-12-03
Z-0878-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-12-03
Z-0879-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-12-03

Product code MUE

K151645Class IIMAMMOMAT FusionSiemens Medical Solutions USA, Inc. / cleared 2015-09-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)