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U.S. Department of Health and Human Services

Class 2 Device Recall Mammography Xray system.

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  Class 2 Device Recall Mammography Xray system. see related information
Date Initiated by Firm May 21, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 16, 2004
Recall Number Z-1094-04
Recall Event ID 29201
PMA Number P010017 
Product Classification Full Field Digital, System, X-Ray, Mammographic - Product Code MUE
Product Fischer SenoScan True View Digital Mammography System.
Code Information Product number 94829G-1, 94830G-1, 94830G-2.
Recalling Firm/
Manufacturer		 Fischer Imaging Corporation
12300 Grant St
Denver CO 80241-3120
For Additional Information Contact
303-254-2525
Manufacturer Reason
for Recall		 Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.
FDA Determined
Cause 2		 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.
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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