Class 2 Device Recall

• Date Initiated by Firm: October 06, 2004
• Date Posted: December 02, 2004
• Recall Status: Terminated on September 02, 2005
• Recall Number: Z-0270-05
• Recall Event ID: 30408
• 510(K)Number: K002531 K023511 K961092 K990620 K993803
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Magnetic Resonance Imaging Systems under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN Excelart VANTAGE
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: Toshiba American Med Sys Inc; 2441 Michelle Dr; Tustin CA 92781
• For Additional Information Contact: Michaela Mahl; 714-730-5000
• Manufacturer Reason for Recall: Software defect causes images to be rotated 180 degrees.
• FDA Determined Cause: Other
• Action: Firm sent a letter to consignees October 6, 2004 describing the observed conditions causing the flaw to manifest itself. A workaround solution is also described in the letter. A software correction is under development and will be installed by a TAMS representative in the future.
• Quantity in Commerce: 67
• 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