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U.S. Department of Health and Human Services

Class 2 Device Recall Digital mammography system.

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  Class 2 Device Recall Digital mammography system. see related information
Date Initiated by Firm March 27, 2006
Date Posted April 11, 2006
Recall Status1 Terminated 3 on March 13, 2012
Recall Number Z-0757-06
Recall Event ID 34975
PMA Number P010017S007 
Product Classification Digital mammography system. - Product Code MUE
Product SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G
Code Information Software versions earlier than 5.2.2  Product Number 94001G-3, 105200G
Recalling Firm/
Manufacturer		 Fischer Imaging Corporation
12300 North Grant Street
Denver CO 80241-3120
For Additional Information Contact
303-254-2585
Manufacturer Reason
for Recall		 Software upgrade to preclude lost images during mammography procedure.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MUE and Original Applicant = HOLOGIC, INC.
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