Class 2 Device Recall

• Date Initiated by Firm: September 21, 2005
• Date Posted: November 24, 2005
• Recall Status: Terminated on July 12, 2007
• Recall Number: Z-0198-06
• Recall Event ID: 33694
• Product Classification: System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
• Product: High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.
• Code Information: model numbers: XTP-8100G AND XTBP-8100G
• 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: It was found during a study, arcing might occur in the transformer of the high voltage generator, XTP-8100G and XTBP-8100G displaying an error message and interrupting fluoroscopy.
• FDA Determined Cause: Other
• Action: Consignees notification that a local TAMS service representative will schedule the implementation of the replacement transformer.
• Quantity in Commerce: 30
• Distribution: CA, CO, KS, IL, LA, IN, ME, MI, NC, NJ, NY, OH, PA, TX
• 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.