| Class 2 Device Recall CHVH001A/1B Variable Helical Pitch (vHP) Software for TSX101A: Aquilion 64 | |
Date Initiated by Firm | April 09, 2010 |
Date Posted | May 19, 2011 |
Recall Status1 |
Terminated 3 on August 17, 2012 |
Recall Number | Z-2204-2011 |
Recall Event ID |
55542 |
510(K)Number | K080211 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed |
Code Information |
SERIAL NUMBERS: 2089, 2114, 2302, 3204, 2037, 2014, 2040, 2898, 2054, 2042, 2067, 2202, 2241, 2100, 2038, 2101, 2102, 2244, 2097, 2931, 2900, 3085, 2412, 2595, 2106, 2041, 2108, 2113, 2130, 2135, 2147, 2158, 2063, 2157, 2161, and 2243. |
Recalling Firm/ Manufacturer |
Toshiba American Medical Systems Inc 2441 Michelle Dr P.O. Box 2068 Tustin CA 92781-2068
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For Additional Information Contact | 714-730-5000 |
Manufacturer Reason for Recall | 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). |
FDA Determined Cause 2 | Software design |
Action | 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 raffairs@tams.com. 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 | 35 |
Distribution | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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