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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 April 12, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 26, 2004
Recall Number Z-0939-04
Recall Event ID 28818
PMA Number P010017 
Product Classification Assembly, Tube Housing, X-Ray, Diagnostic - Product Code ITY
Product SenoScan True View Digital Mammography System
Code Information Serial Numbers: 9800-0103-001, 9800-0104-001, 0900-0104-002, 9800-0104-003, 9800-0203-001, 9800-0204-001, 9800-0204-002, 9800-0204-004, 9800-0204-005, 9800-0303-003, 9800-0402-003, 9800 0403-001, 9800-0502-001, 9800-0602-001R, 9800-0603-001, 9800-0603-002, 9800-0901-001R, 9800-0903-001, 9800-1001-001, 9800-1003-003, 9800-1003-004, 9800-1102-003, 9800-1102-007, 9800-1103-001, 9800-1103-002, 9800-1103-003, 9800-1103-004, 9800-1103-005, 9800-1103-006, 9800-1103-007, 9800-1103-008, 9800-1103-009, 9800-1103-011, 9800-1103-012, 9800-1202-003, 9800-1203-001, 9800-1203-002.  
Recalling Firm/
Manufacturer		 Fischer Imaging Corporation
12300 Grant St
Denver CO 80241-3120
For Additional Information Contact
303-254-2525
Manufacturer Reason
for Recall		 X-ray tube may overheat after high usage because of mis-wired thermal switch circuit.
FDA Determined
Cause 2		 Other
Action Customers were notified by certified mail on 4/19/2004.
Quantity in Commerce 37
Distribution Nationwide CA, CO, FL, IN, MA, MO, NC, NY, OK, TX, WI, Mexico, France. No government or military distribution.
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.
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