Z-1318-2009

Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system

Name: Z-1318-2009 Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-01-21
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-01-21 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system on 2009-01-21. The reason FDA records is "Table may unintentionally lift during procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1318-2009
Status: Terminated
Initiated: 2009-01-21
Posted: 2009-06-01
Terminated: 2009-06-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: Table may unintentionally lift during procedure
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens Medical Solutions issued a Safety Advisory Notice dated 1/22/09 which informs the customers of the potential issues and recommends that they stop using their MammoTest System until the prone table has been repaired. Linear Medical visited the customers to repair the weld joint on the prone table by January 23, 2009.
Quantity in commerce: 4 units
Distribution: USA distribution to IL, NY, SC, and WA
Product codes and lots: Serial numbers 10102, 10103, 10105, and 10106

Product code JAQ

K042095Class IIMammotestFischer Imaging Corp. / cleared 2004-10-29

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)