Recall Z-1034-2012 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
TSX-301A: AQUILION ONE; System, X-Ray, Tomography, Computed Last four of Serial Number: 2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 2072, 2077, 2080, 2092, 2115, 2116, 2123, 2131, 2133, 2139, 2143, 2148, 2151, 2158, 2161, 2162, 2165, 2167, 2168, 2169, 2170, 2174, 2208, 2211, 2212, 2219, 2220, 2222, 2241, 2253, 2257, 2265, 2275, 2283,
| Date | Feb 15, 2012 (initiated Jan 3, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 82 units total |
| Distribution | Nationwide Distribution - USA (nationwide) and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083282 | MODEL TSX-301B AQUILION CT SYSTEM Toshiba America Medical Systems, In.C, Dec 12, 2008 |