Class 2 Device Recall General Radiographic System

• Date Initiated by Firm: April 23, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on March 13, 2012
• Recall Number: Z-0974-04
• Recall Event ID: 28995
• 510(K)Number: K880530
• Product Classification: Tube Mount, X-Ray, Diagnostic - Product Code IYB
• Product: VersaRad/Traumex General Radiographic System.
• Code Information: All units.
• Recalling Firm/ Manufacturer: Fischer Imaging Corporation; 12300 Grant St; Denver CO 80241-3120
• For Additional Information Contact: 303-254-2525
• Manufacturer Reason for Recall: If two of the four T-nuts that connect the transverse rail to the ceiling rail fail, the 'U' arm and transverse rails could fall and cause serious injury.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 4/23/2004.
• Quantity in Commerce: 138 units
• Distribution: Nationwide, including VA facilities in MI, MN and VT. No military consignees. Foreign distribution to Australia, Canada, Denmark, Italy, Korea, Netherlands, Norway, Sweden, United Kingdom.
• 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 = IYB and Original Applicant = FISCHER IMAGING CORP.