| ||Class 2 Device Recall TSXIOI: AQUILION 32/64; System |
||April 08, 2013
||Terminated on June 17, 2013
|Recall Event ID
System, x-ray, tomography, computed -
||TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed.
Designed to produce cross-sectional images of a human body.
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
|For Additional Information Contact
|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.
||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
||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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.