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