Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
FDA device recall Z-1068-2013 · posted 2013-04-08 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.
- Action taken
- Toshiba American Medical Systems Inc. sent a Urgent Medical Device Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer was informed a New software to prevent the occurrence of this issue will be installed on your system. Toshiba Service Representative will contact you for an appointment to install the New Software on your Aquilion One System. Please fax the return reply form to (877) 349-3054. We thank you for your urgent attention to this matter. If you have any further questions regarding this letter please call (800) 521-1968.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 1 unit
- Distribution
- Distributed in the state of MD.
- Date initiated
- 2012-11-14
- Date posted
- 2013-04-08
- Date terminated
- 2013-04-08
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUILION ONE VISION, V4.90 (K122109) | Toshiba America Medical Systems, In.C | 2012-09-21 |