Class 3 Device Recall Toshiba Excelart V ANT AGE Model MRT1503

• Date Initiated by Firm: October 12, 2005
• Date Posted: December 14, 2005
• Recall Status: Terminated on July 12, 2007
• Recall Number: Z-0281-06
• Recall Event ID: 33997
• 510(K)Number: K032490
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
• Code Information: Serial Numbers: A4622037, A4612031, A4622017, A4532013, A4582010, A5532048, A4592013, A4532012, A5532022, A4602028, A3592003, A4522007, A5512041, A4612015, A4572020, A4602029, A4622039, A4612030, A4542015, A4602014, A4602026, A4622036, A5522045, A5532047, A4612033, A5512040, A4612032, A4562003, A4572004, A4592012, A4562018, A4622035, A4522009, A4602025, A3582001, A5512043, A45320 11, A4602024, A5512018, A4572006, A4572023, A5512019, A5532049, A3592002, A4602027, A4552002, A4512006, A4552017, A5522046, A4572005, A4562019, A4572021, A4522008, A4612034, A4582009, A3612004, A4622016, A4532010, A3622001, A5512044, A4552016, A4572007, A4592011, A4572008, & A5512042
• FEI Number: 2020563
• 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: To correct a hardware problem of water leakage in the cooling system inside the ASGC, leading to the replacement of the gradient coil.
• FDA Determined Cause: Other
• Action: Toshiba America Medical Systems, Inc., (TAMS) customer service engineers will hand deliver The Advisory Letter and monitor the system during their monthly preventive maintenance.
• Quantity in Commerce: 65
• 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