TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
This recall has been terminated (originally issued April 8, 2013).
- Recall Initiated
- November 30, 2011
- Posted
- April 8, 2013
- Terminated
- June 17, 2013
- Recall Number
- Z-1067-2013
- Quantity
- 23 units
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution including the states of WA, OH, CA, TX, WV, IL, AZ, CA, WI, ME, WI, NC, FL, MT, and HI.
Lot / Code Info
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
Root Cause
Process design
Action Taken
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.