| ||Class 2 Recall|
CHVH001A/1B Variable Helical Pitch (vHP) Software for TSX101A: Aquilion 64
||May 19, 2011
||Terminated on August 17, 2012
|Recall Event ID
System, X-Ray, Tomography, Computed - Product Code JAK
||CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed
|Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92781-2068
|The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement speed).
|DESIGN: Software Design
||Toshiba America Medical Systems (TAMS) forwarded an Urgent: Medical Device Correction letter, dated 4/6/10, with attached Customer Reply Form, via US Postal Service to all customers who purchased the CHVH-001A/1B variable helical pitch (vHP) software for TSX-I0IA: Aquilion 64. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were informed that a Toshiba service representative would contact them to schedule an appointment in order to install a corrective measure that will prevent the occurrence of the problem. Toshiba would like customers to set a scan range different from that for the previous scan for the second and subsequent vHP scans, if multiple vHP scans with the same scan conditions are performed in Auto Mode.
Customers were instructed to complete and return the attached form and fax it to the toll free number at the top of the form. The form can also be sent via e-mail to firstname.lastname@example.org. Customers with any questions can contact the Director of Regulatory Affairs at (800) 421-1968 or contact their local Representative at (800) 521-1968.
|Quantity in Commerce
||Nationwide Distribution -- MN, OH, MO, MI, NY, KS, MD, TX, NJ, IL, ID, TN, AZ, PA, HI, GA, MT, WA, FL, NC, WI, ME, & CA.
|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.