Class 2 Device Recall Mini View (GE) Mobile Carm fluoroscopic xray system.

• Date Initiated by Firm: March 28, 2006
• Date Posted: September 30, 2006
• Recall Status: Terminated on July 25, 2011
• Recall Number: Z-0704-06
• Recall Event ID: 34990
• 510(K)Number: K992506
• Product Classification: X ray system - Product Code JAA
• Product: MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.
• Code Information: All MiniView 6800 systems.
• FEI Number: 1720753
• Recalling Firm/ Manufacturer: GE OEC Medical Systems,Inc; 384 Wright Brothers Dr; Salt Lake City UT 84116-2862
• For Additional Information Contact: 801-328-9300
• Manufacturer Reason for Recall: Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter prior to 04/28/2006.
• Quantity in Commerce: 534 units (Domestic), 125 (Intl)
• Distribution: Nationwide.
• 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 = JAA