| Class 2 Device Recall Aquilion One Whole Body XRay CT Scanner | |
Date Initiated by Firm | January 07, 2010 |
Date Posted | March 02, 2010 |
Recall Status1 |
Terminated 3 on September 12, 2012 |
Recall Number | Z-0907-2010 |
Recall Event ID |
54258 |
510(K)Number | K083282 |
Product Classification |
X-Ray, Tomography, Computed - Product Code JAK
|
Product | Aquilion One Whole Body X-Ray CT Scanner
Whole body computed tomography scanning |
Code Information |
Serial Numbers: 1DA0962006, 1DA0972007, 2DA0792002, 2DA0792004, 2DA07X2005, 2DA07X2008, 2DA07Y2010, 2DA0842023, 2DA0842026, 2DA0862034, 2DA0862036, 2DA0872038, 2DA0882048, 2DA0882049, 2DA0882051, 2DA0882052, 2DA0882053, 2DA08X2061, 2DA08X2063, 2DA08X2067, 2DA08X2070, 2DA08X2071, 2DA08X2072, 2DA08Y2077, 2DA08Y2080, 2DA08Z2092, 2DA0952115, and 2DA0962116 |
Recalling Firm/ Manufacturer |
Toshiba American Medical Systems Inc 2441 Michelle Dr P.O. Box 2068 Tustin CA 92780-7047
|
For Additional Information Contact | 714-730-5000 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | 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 in Commerce | 28 units |
Distribution | Nationwide: AL AR AZ CA CO FL GA IA MA MD ND NJ NV NY OH PA PR andVA |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JAK
|
|
|
|