Class 3 Device Recall

• Date Initiated by Firm: May 06, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on March 15, 2005
• Recall Number: Z-0937-04
• Recall Event ID: 29020
• 510(K)Number: K002531 K933018 K961092 K990620 K993803
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems.
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: Toshiba American Med Sys Inc; 2441 Michelle Dr; Tustin CA 92781
• For Additional Information Contact: Paul Biggins; 715-730-5000
• Manufacturer Reason for Recall: Software anomaly.
• FDA Determined Cause: Other
• Action: Firm will send letters followed by visits to install software repair.
• Quantity in Commerce: 50
• 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 = LNH; 510(K)s with Product Code = LNH