Recall Z-1067-2013— Toshiba American Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2011-11-30, terminated 2013-06-17. FDA's recall record names no specific 510(k) clearance for this event. Product: TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.. Reason: 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
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-11-30
- Terminated
- 2013-06-17
- Firm location
- Tustin, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.