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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 FirmApril 12, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on July 26, 2004
Recall NumberZ-0939-04
Recall Event ID 28818
PMA NumberP010017 
Product Classification Assembly, Tube Housing, X-Ray, Diagnostic - Product Code ITY
ProductSenoScan 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
ActionCustomers were notified by certified mail on 4/19/2004.
Quantity in Commerce37
DistributionNationwide CA, CO, FL, IN, MA, MO, NC, NY, OK, TX, WI, Mexico, France. No government or military distribution.
Total Product Life CycleTPLC 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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