Aquilion One Whole Body X-Ray CT Scanner Whole body computed tomography scanning
FDA Recall Z-0907-2010 · Posted 2010-03-02
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Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2010-01-07
Date Terminated2012-09-12
Product Quantity28 units
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.
Firm 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 [email protected]. Contact: Paul Biggins
Root Cause
Device Design
Distribution Pattern
Nationwide: AL AR AZ CA CO FL GA IA MA MD ND NJ NV NY OH PA PR andVA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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