Z-1067-2013Class II

TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a...

Name: Z-1067-2013 TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a...
Creator: Toshiba American Medical Systems Inc
Published: 2011-11-30
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2011-11-30 / Terminated / root cause: manufacturing process

FDA source

Toshiba American Medical Systems Inc began a recall of TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body on 2011-11-30. FDA classified it as Class II and gives the reason as "The firm initiated this recall due to a potential software issue. The DLP (Dose Length Product) value may be displayed incorrectly when the vHP option is used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1067-2013
Classification: Class II
Status: Terminated
Initiated: 2011-11-30
Posted: 2013-04-08
Terminated: 2013-06-17
Recalling firm: Canon Medical Systems USA, Inc.
Product: TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The firm initiated this recall due to a potential software issue. The DLP (Dose Length Product) value may be displayed incorrectly when the vHP option is used.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Toshiba sent "URGENT: MEDICAL DEVICE CORRECTION" letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter contained a return reply form that is to be faxed to TAMS for retention. Contact the firm at (800) 421-1968 for questions relating to this letter.
Quantity in commerce: 23 units
Distribution: Nationwide Distribution including the states of WA, OH, CA, TX, WV, IL, AZ, CA, WI, ME, WI, NC, FL, MT, and HI.
Product codes and lots: Serial Numbers: HDA0722595 JDA0972130 JDA0972135 JDA0992147 JDA09Y2158 KDA09X2063 JDA09Y2157 JDA09Y2161 JDA1012171 JDA10X2191 JDA10X2197 JDA10Z2214 JGAl112220 JLA1122232 JLA1132235 JDAl112216 JDAl112219 NLA0972032 JDA1182242 JDA1182241 JDA1182244 JDA1072183 JDA1082189

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1067-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1067-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-07

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)