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U.S. Department of Health and Human Services

Class 2 Device Recall TSXIOI: AQUILION 32/64; System

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  Class 2 Device Recall TSXIOI: AQUILION 32/64; System see related information
Date Initiated by Firm November 30, 2011
Date Posting Updated April 08, 2013
Recall Status1 Terminated 3 on June 17, 2013
Recall Number Z-1067-2013
Recall Event ID 64667
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed.

Designed to produce cross-sectional images of a human body.
Code Information 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

Recalling Firm/
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92780-7047
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

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.