Z-0379-05

MammoTest Breast Biopsy System

Name: Z-0379-05 MammoTest Breast Biopsy System
Creator: Fischer Imaging Corporation
Published: 2004-07-09
License: https://open.fda.gov/license/

Fischer Imaging Corp. / initiated 2004-07-09 / Terminated

FDA source

Fischer Imaging Corporation began a recall of MammoTest Breast Biopsy System on 2004-07-09. The reason FDA records is "X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0379-05
Status: Terminated
Initiated: 2004-07-09
Posted: 2005-01-05
Terminated: 2012-03-13
Recalling firm: Fischer Imaging Corp.
Product: MammoTest Breast Biopsy System.
Product code: IZH System, X-Ray, Mammographic
Reason for recall: X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.
FDA root cause: Other
Action: Consignees were notified by letter on 7/9/2004.
Quantity in commerce: 860 units
Distribution: Nationwide, including VA facility in AR, military facilities in CA, FL, GA, MD, MO, NC, TX. Foreign distribution to Austria, Belgium, Canada, Czech Republic, France, Germany, Greece, Italy, Norway, Poland, Portugal, Russia, Saudi Arabia, Spain, Switzerland, The Netherlands, UK.
Product codes and lots: All units

Product code IZH

K861692Class IIFischer Pps/mammotest Mammography SystemFischer Imaging Corp. / cleared 1986-12-15

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)