Class 2 Device Recall Aquilion One CT System, TSX301A/2

• Date Initiated by Firm: July 13, 2009
• Date Posted: August 28, 2012
• Recall Status: Terminated on September 04, 2012
• Recall Number: Z-2282-2012
• Recall Event ID: 53055
• 510(K)Number: K072606
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Whole Body X--ray Scanner; ; This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
• Code Information: Serial Number: 2DA0882051
• Recalling Firm/ Manufacturer: Toshiba American Medical Systems Inc; 2441 Michelle Dr; P.O. Box 2068; Tustin CA 92780-7047
• For Additional Information Contact: 714-730-5000
• Manufacturer Reason for Recall: 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco
• FDA Determined Cause: Software design
• Action: The firm, Toshiba America Medical Systems, Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 30, 2009 to its Consignees/customers. The letter described the product, problem and actions to be taken. The letter informed them of the above mentioned reason for recall and telling them that a corrective measure will be installed to prevent the occurrence of the above problems. They were told that their Toshiba service representative will contact them to install the measures. Furthermore Toshiba instructed them to adopt the following temporary measures to avoid these phenomena until corrective measures have been taken. 1. When performing raw data processing for Go&Return helical scan, select the raw data acquired for Go and that acquired for Return separately in order to perform reconstruction 2. When using the Sure Exposure 3D function, confirm that the error message shown in the preceding page is not displayed on the monitor at the time of setup (until the Scan Start button lights after the Confirm button is clicked). 3. When executing an eXam Plan in which Sure Exposure 3D is selected as the actual scan for Sure Start, confirm that the error message show in the preceding page is not displayed on the monitor when monitoring scan is switched to the actual scan. If the error message is displayed, click [OK] in the error message dialog to continue processing. The letter should be shared with facility's Biomedical or Clinical Engineering Department. Also the customers were instructed to complete and return the Customer Reply Form via fax to: Regulatory Affairs at 877-349-3054. If you have any questions regarding this letter, contact Director, Regulatory Affairs at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968 with any questions regarding the letter.
• Quantity in Commerce: 24 Systems
• Distribution: Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA 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 = JAK and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.