Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner
FDA device recall Z-1257-2011 · posted 2011-02-15 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. This results in a pre-scan expected dose that is approximately 10% lower than what the displayed value should be when the scanner executes the exam Plan.
- Action taken
- Toshiba America Medical Systems (TAMS) issued notification to consignees 9/7/2010, via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 44 units distributed between 09/2007 - 07/2010
- Distribution
- Nationwide distribution.
- Date initiated
- 2010-09-07
- Date posted
- 2011-02-15
- Date terminated
- 2012-04-20
- Location
- Tustin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL TSX-301B AQUILION CT SYSTEM (K083282) | Toshiba America Medical Systems, In.C | 2008-12-12 |