Z-1094-04

Fischer SenoScan True View Digital Mammography System

Name: Z-1094-04 Fischer SenoScan True View Digital Mammography System
Creator: Fischer Imaging Corporation
Published: 2004-05-21
License: https://open.fda.gov/license/

Fischer Imaging Corp. / initiated 2004-05-21 / Terminated / root cause: software

FDA source

Fischer Imaging Corporation began a recall of Fischer SenoScan True View Digital Mammography System on 2004-05-21. The reason FDA records is "Existing software may allow Image data to be truncated in the margin of the breast on processed patient images". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1094-04
Status: Terminated
Initiated: 2004-05-21
Posted: 2004-07-20
Terminated: 2004-07-16
Recalling firm: Fischer Imaging Corp.
Product: Fischer SenoScan True View Digital Mammography System.
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.
Root cause tag: software
FDA root cause: Other
Action: Customers were notified by phone and certified letter on 05/21/2004.
Quantity in commerce: 12 units
Distribution: FL, NC, NY, OK, WI. Foreign distribution to France.
Product codes and lots: Product number 94829G-1, 94830G-1, 94830G-2.

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