FDA-Device2013-04-17Class II

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
Hazard

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.

Sold states
Nationwide Distribution including the states of WA, OH, CA, TX, WV, IL, AZ, CA, WI, ME, WI, NC, FL, MT, and HI.
Affected count
23 units
Manufactured in
2441 Michelle Dr, P.O. Box 2068, Tustin, CA, United States
Products
TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1067-2013

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