Recall Z-2204-2011 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed
| Date | May 19, 2011 (initiated Apr 9, 2010) |
| Status | Terminated |
| Reason | The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement speed). |
| Root cause | Software design |
| Action | Toshiba America Medical Systems (TAMS) forwarded an Urgent: Medical Device Correction letter, dated 4/6/10, with attached Customer Reply Form, via US Postal Service to all customers who purchased the CHVH-001A/1B variable helical pitch (vHP) software for TSX-I0IA: Aquilion 64. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were informed that a Toshiba service representative would contact them to schedule an appointment in order to install a corrective measure that will prevent the occurrence of the problem. Toshiba would li |
| Quantity | 35 |
| Distribution | Nationwide Distribution -- MN, OH, MO, MI, NY, KS, MD, TX, NJ, IL, ID, TN, AZ, PA, HI, GA, MT, WA, FL, NC, WI, ME, & CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080211 | MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM Toshiba America Medical Systems, In.C, Mar 14, 2008 |