TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body
FDA device recall Z-1067-2013 · posted 2013-04-08 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- 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.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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.
- Date initiated
- 2011-11-30
- Date posted
- 2013-04-08
- Date terminated
- 2013-06-17
- Location
- Tustin, CA
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