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U.S. Department of Health and Human Services

Class 2 Device Recall TSX301B: AQUILION ONE; System, XRay, Tomography, Computed

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  Class 2 Device Recall TSX301B: AQUILION ONE; System, XRay, Tomography, Computed see related information
Date Initiated by Firm January 03, 2012
Date Posted February 15, 2012
Recall Status1 Terminated 3 on April 08, 2013
Recall Number Z-1035-2012
Recall Event ID 61111
510(K)Number K083282  
Product Classification System, X-ray, Tomography, computed - Product Code JAK
Product TSX-301B: AQUILION ONE; System, X-Ray, Tomography, Computed

Last four of Serial Number:
2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 2072, 2077, 2080, 2092, 2115, 2116, 2123, 2131, 2133, 2139, 2143, 2148, 2151, 2158, 2161, 2162, 2165, 2167, 2168, 2169, 2170, 2174, 2208, 2211, 2212, 2219, 2220, 2222, 2241, 2253, 2257, 2265, 2275, 2283, 2284, 2291, 2294, 2308, 2311, 2316, 2324, 2328, 2332, 2333, 2006, 2007, 2008, 2011, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2025, 2027, 2030, 2031, 2032, 2033, 2035, 2002, 2004.

Aquilion One is a multislice CT system that supports whole body scanning. The system supports simultaneous data aquisition of 320 slices using the Selectable Slice-thickness Multi-row Detector (SSMD). In addition, the high speed rotation mechanism and the reconstruction unit of the system allow quick image acquisition to further improve throughput in CT examinations. Aquilion ONE, Toshiba's top of the line X-ray CT system, is provided with a 7.5 MHU large capacity X-ray tube unit and detector and permits scanning at the high speed per rotation.
Code Information Lot number is not utilized
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 The recall was initiated because Toshiba has confirmed that their is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One.
FDA Determined
Cause 2		 Software design
Action Toshiba sent an Urgent Medical Device Correction letter to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete and fax the attached form to (877) 349-3054. The form can also be sent via email to raffairs@tams.com. Customers with any questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
Quantity in Commerce 82 units total
Distribution Nationwide Distribution - USA (nationwide) 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.
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