Class 2 Device Recall

• Date Initiated by Firm: June 07, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on January 04, 2005
• Recall Number: Z-1045-04
• Recall Event ID: 29226
• 510(K)Number: K002531 K023511 K961092 K990620
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Magnetic Resonance Imaging System(s) Visart and Exelart P2/ Exelart P3/ Exelart SPIN and Exelart VANTAGE
• 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; 714-730-5000
• Manufacturer Reason for Recall: Wrong positioning may cause patient burns.
• FDA Determined Cause: Other
• Action: An advisory letter will issue to all users May 26, 2004, with updated positioning information, and an employee will visit to make sure the letter was received and understood.
• Quantity in Commerce: 58
• 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