Z-0757-06

SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G

Name: Z-0757-06 SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G
Creator: Fischer Imaging Corporation
Published: 2006-03-27
License: https://open.fda.gov/license/

Fischer Imaging Corp. / initiated 2006-03-27 / Terminated / root cause: software

FDA source

Fischer Imaging Corporation began a recall of SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G on 2006-03-27. The reason FDA records is "Software upgrade to preclude lost images during mammography procedure". 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-0757-06
Status: Terminated
Initiated: 2006-03-27
Posted: 2006-04-11
Terminated: 2012-03-13
Recalling firm: Fischer Imaging Corp.
Product: SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: Software upgrade to preclude lost images during mammography procedure.
Root cause tag: software
FDA root cause: Other
Action: Consignees were notified by letter on 03/27/2006.
Quantity in commerce: 80 units.(Domestic) Foreign list pending
Distribution: Nationwide. AZ, CA, CO, FL, GA, IL, IN, KS, MA, MI, MN, MT, NY, OK, SC, TX, WA, WI, WV. No government or military consignees.
Product codes and lots: Software versions earlier than 5.2.2 Product Number 94001G-3, 105200G

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)