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Terminated

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.

FDA Recall Z-1035-2012 · Posted 2012-02-15

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2012-01-03
Date Terminated2013-04-08
Product Quantity82 units total

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.

Firm 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 [email protected]. Customers with any questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution - USA (nationwide) and Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083282MODEL TSX-301B AQUILION CT SYSTEMToshiba America Medical Systems, In.C · 2008-12-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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