Z-0523-2012

MAMMOMAT Inspiration Full field digital mammographic x-ray system

Name: Z-0523-2012 MAMMOMAT Inspiration Full field digital mammographic x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-09-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-09-15 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of MAMMOMAT Inspiration Full field digital mammographic x-ray system on 2011-09-15. The reason FDA records is "Lowering the swivel arm with "object table" while an operator's or patient's body parts are underneath the "object table" may cause the "object table" to collide with and injure the operator or patient. Therefore...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0523-2012
Status: Terminated
Initiated: 2011-09-15
Posted: 2012-01-11
Terminated: 2014-03-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MAMMOMAT Inspiration Full field digital mammographic x-ray system
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: Lowering the swivel arm with "object table" while an operator's or patient's body parts are underneath the "object table" may cause the "object table" to collide with and injure the operator or patient. Therefore attention should be paid when adjusting "object table" height to avoid a possible risk of injury to the operator or the patient. The movement of the swivel arm may also cause an injur
FDA root cause: Use error
Action: Siemens Medical Solutions USA, Inc sent a Safety Advisory Notice dated January 8, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The notification included an Addendum to the User Manual. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your operating personnel accordingly. Please ensure that this safety advisory is placed in the System's Operator Manual. Your operating personnel should maintain awareness over an appropriate defined period. Further questions please call (610) 219-4834.
Quantity in commerce: 12
Distribution: Nationwide Distribution including the states of FL, MD, MI, NE, NY, NC, ND, OH, and SC.
Product codes and lots: Model number 10140000

Product code MUE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)