Recall Z-0907-2010 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
Aquilion One Whole Body X-Ray CT Scanner Whole body computed tomography scanning
| Date | Mar 2, 2010 (initiated Jan 7, 2010) |
| Status | Terminated |
| Reason | When W-Volume is performed in Prospective CTA or Target CTA studies with ECG gating, unnecessary intervals may be set before starting the volume scan. As a result, scanning cannot be performed at the appropriate timing of constant enhancement and clinically useful images may not be obtained. |
| Root cause | Device Design |
| Action | A corrective measure will be installed to prevent measures to avoid this phenomenon until corrective actions have been taken. Customers are advised: (1) When performing scanning in Prospective CTA or Target CTA studies with ECG gating, do not use W-Volume scanning but use Helical Scanning. (2) Please share this information with all users and reviewing radiologists as well as clinical engineering or Biomedical group at facility (3) Please complete and return the attached form and fax it to the toll-free number at the top or by email to raffairs@tams.com. Contact: Paul Biggins |
| Quantity | 28 units |
| Distribution | Nationwide: AL AR AZ CA CO FL GA IA MA MD ND NJ NV NY OH PA PR andVA |
| 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 |