TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectio...
FDA Recall #Z-1067-2013 — Class II — November 30, 2011
Product Description
TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
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.
Recalling Firm
Toshiba American Medical Systems Inc — Tustin, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated