Z-1665-2011

TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that supports whole body scanning. The...

Name: Z-1665-2011 TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that supports whole body scanning. The...
Creator: Toshiba American Medical Systems Inc
Published: 2010-07-22
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2010-07-22 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of... on 2010-07-22. The reason FDA records is "Toshiba America Medical Systems (TAMS) has found that communication may be cut off in the Aquilion ONE/ Premium Systems, owing to the failure of a part used in the console". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1665-2011
Status: Terminated
Initiated: 2010-07-22
Posted: 2011-03-16
Terminated: 2011-04-05
Recalling firm: Canon Medical Systems USA, Inc.
Product: TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thickness Multi-row Detector.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Toshiba America Medical Systems (TAMS) has found that communication may be cut off in the Aquilion ONE/ Premium Systems, owing to the failure of a part used in the console.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Toshiba America Medical Systems (TAMS), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 22, 2010, to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that a new relay will be installed to prevent the occurrence of the problem within the next 90 days and that their Toshiba Service Representative will contact them to install the part to their Aquilion ONE/Premium System. The customers were instructed to contact their Toshiba Service Representative, if the problem occurs before the corrective action has been taken; to share the information with all users and review radiologists as well as clinical engineering or Biomedical group at their facility, and to complete and return the attached CUSTOMER REPLY FORM via fax to 877-349-3054 or email to [email protected]. If you have any questions regarding this letter, please feel free to contact the Director, Regulator Affairs at (800) 421-1968 or your local Toshiba Representative at (800) 521-1968.
Quantity in commerce: 43 units
Distribution: Nationwide distribution: USA including states of: AL, AR, AZ, CA, CO, FL, GA, IA, KY, LA, MA, MD, MI, MN, MT, ND, NJ, NV, NY, OH, PA, PR, TX, VA, WI, and WY.
Product codes and lots: Last 4 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, 2006, 2007, 2008, 2123, 2131, 2133, 2011, 2139, 2143, 2148, 2151, 2014, 2161, 2162, 2165, 2167, 2168, 2169, 2170, 2002, 2004, 2158, 2166, 2174

Product code JAK

K083282Class IIModel Tsx-301B Aquilion CT SystemToshiba America Medical Systems, In.C / cleared 2008-12-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)