Class 2 Device Recall Digital mammography system.

• Date Initiated by Firm: March 27, 2006
• Date Posted: April 11, 2006
• Recall Status: Terminated 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: 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