Z-0907-2010

Aquilion One Whole Body X-Ray CT Scanner Whole body computed tomography scanning

Name: Z-0907-2010 Aquilion One Whole Body X-Ray CT Scanner Whole body computed tomography scanning
Creator: Toshiba American Medical Systems Inc
Published: 2010-01-07
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2010-01-07 / Terminated / root cause: design

FDA source

Toshiba American Medical Systems Inc began a recall of Aquilion One Whole Body X-Ray CT Scanner Whole body computed tomography scanning on 2010-01-07. The reason FDA records is "When W-Volume is performed in Prospective CTA or Target CTA studies with ECG gating, unnecessary intervals may be set before starting the volume scan. As a result, scanning cannot be performed at the appropriate timing...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0907-2010
Status: Terminated
Initiated: 2010-01-07
Posted: 2010-03-02
Terminated: 2012-09-12
Recalling firm: Canon Medical Systems USA, Inc.
Product: Aquilion One Whole Body X-Ray CT Scanner Whole body computed tomography scanning
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: When W-Volume is performed in Prospective CTA or Target CTA studies with ECG gating, unnecessary intervals may be set before starting the volume scan. As a result, scanning cannot be performed at the appropriate timing of constant enhancement and clinically useful images may not be obtained.
Root cause tag: design
FDA root cause: Device Design
Action: A corrective measure will be installed to prevent measures to avoid this phenomenon until corrective actions have been taken. Customers are advised: (1) When performing scanning in Prospective CTA or Target CTA studies with ECG gating, do not use W-Volume scanning but use Helical Scanning. (2) Please share this information with all users and reviewing radiologists as well as clinical engineering or Biomedical group at facility (3) Please complete and return the attached form and fax it to the toll-free number at the top or by email to [email protected]. Contact: Paul Biggins
Quantity in commerce: 28 units
Distribution: Nationwide: AL AR AZ CA CO FL GA IA MA MD ND NJ NV NY OH PA PR andVA
Product codes and lots: Serial Numbers: 1DA0962006, 1DA0972007, 2DA0792002, 2DA0792004, 2DA07X2005, 2DA07X2008, 2DA07Y2010, 2DA0842023, 2DA0842026, 2DA0862034, 2DA0862036, 2DA0872038, 2DA0882048, 2DA0882049, 2DA0882051, 2DA0882052, 2DA0882053, 2DA08X2061, 2DA08X2063, 2DA08X2067, 2DA08X2070, 2DA08X2071, 2DA08X2072, 2DA08Y2077, 2DA08Y2080, 2DA08Z2092, 2DA0952115, and 2DA0962116

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)