Class 3 Device Recall Toshiba

• Date Initiated by Firm: January 27, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on July 13, 2005
• Recall Number: Z-0546-04
• Recall Event ID: 28184
• 510(K)Number: K933018 K961092 K990620
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.
• Code Information: Flexart systems with software V3.51*R534 to V4.10*R551. Visart systems with software V3.51*R234 to V4.10*R251. Excelart systems with softare V4.04*R251 to V4.10*R271.
• 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: Software anomally causes image slices to be in incorrect order.
• FDA Determined Cause: Other
• Action: Firm sent letters to customers 1/28/2004 which explains how to avoid the adverse event and announces that a software fix is going to be made available.
• Quantity in Commerce: 24
• Distribution: NV, CO, OH, PA, CA, TN, FL, TX, OK, OR, NY, NJ and Puerto Rico.
• 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