Class 2 Device Recall MammoTest System

• Date Initiated by Firm: July 09, 2004
• Date Posted: January 05, 2005
• Recall Status: Terminated on March 13, 2012
• Recall Number: Z-0379-05
• Recall Event ID: 29575
• 510(K)Number: K861692
• Product Classification: System, X-Ray, Mammographic - Product Code IZH
• Product: MammoTest Breast Biopsy System.
• Code Information: All units
• FEI Number: 1418957
• Recalling Firm/ Manufacturer: Fischer Imaging Corporation; 12300 Grant St; Denver CO 80241-3120
• For Additional Information Contact: Tom Gibson; 303-254-2525
• Manufacturer Reason for Recall: X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 7/9/2004.
• Quantity in Commerce: 860 units
• Distribution: Nationwide, including VA facility in AR, military facilities in CA, FL, GA, MD, MO, NC, TX. Foreign distribution to Austria, Belgium, Canada, Czech Republic, France, Germany, Greece, Italy, Norway, Poland, Portugal, Russia, Saudi Arabia, Spain, Switzerland, The Netherlands, UK.
• 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.

• 510(K) Database: 510(K)s with Product Code = IZH