| ||Class 2 Recall|
TSX301A: AQUILION ONE
||March 16, 2011
||Terminated on April 05, 2011
|Recall Event ID
System, X-Ray, Tomography, Computed - Product Code JAK
||TSX-301A: AQUILION ONE System
AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thickness Multi-row Detector.
||Last 4 of serial number:
|Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92781-2068
|Toshiba America Medical Systems (TAMS) has found that communication may be cut off in the Aquilion ONE/ Premium Systems, owing to the failure of a part used in the console.
|DESIGN: Software Design
||The firm, Toshiba America Medical Systems (TAMS), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 22, 2010, to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that a new relay will be installed to prevent the occurrence of the problem within the next 90 days and that their Toshiba Service Representative will contact them to install the part to their Aquilion ONE/Premium System. The customers were instructed to contact their Toshiba Service Representative, if the problem occurs before the corrective action has been taken; to share the information with all users and review radiologists as well as clinical engineering or Biomedical group at their facility, and to complete and return the attached CUSTOMER REPLY FORM via fax to 877-349-3054 or email to firstname.lastname@example.org.
If you have any questions regarding this letter, please feel free to contact the Director, Regulator Affairs at (800) 421-1968 or your local Toshiba Representative at (800) 521-1968.
|Quantity in Commerce
||Nationwide distribution: USA including states of: AL, AR, AZ, CA, CO, FL, GA, IA, KY, LA, MA, MD, MI, MN, MT, ND, NJ, NV, NY, OH, PA, PR, TX, VA, WI, and WY.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = JAK and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.