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U.S. Department of Health and Human Services

Class 2 Device Recall Aquilion One Whole Body XRay CT Scanner

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 Class 2 Recall
Aquilion One Whole Body XRay CT Scanner
see related information
Date Posted March 02, 2010
Recall Status1 Terminated on September 12, 2012
Recall Number Z-0907-2010
Recall Event ID 54258
Premarket Notification
510(K) Number
K083282 
Product Classification System, 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, California 92780-7047
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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