TSX-301A: AQUILION ONE; System, X-Ray, Tomography, Computed Last four of Serial Number: 2005, 2008, 2010, 2023, 2026, 20
FDA device recall Z-1034-2012 · posted 2012-02-15 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- The recall was initiated because Toshiba has confirmed that their is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One.
- Action taken
- Toshiba sent an Urgent Medical Device Correction letter to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete and fax the attached form to (877) 349-3054. The form can also be sent via email to raffairs@tams.com. Customers with any questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 82 units total
- Distribution
- Nationwide Distribution - USA (nationwide) and Puerto Rico
- Date initiated
- 2012-01-03
- Date posted
- 2012-02-15
- Date terminated
- 2013-04-08
- 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 |