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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

Product Description T SX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
Recall Number Z-1067-2013
Classification Class II
Code Info Serial Numbers: HDA0722595 JDA0972130 JDA0972135 JDA0992147 JDA09Y2158 KDA09X2063 JDA09Y2157 JDA09Y2161 JDA1012171 JDA10X2191 JDA10X2197 JDA10Z2214 JGAl112220 JLA1122232 JLA1132235 JDAl112216 JDAl112219 NLA0972032 JDA1182242 JDA1182241 JDA1182244 JDA1072183 JDA1082189
Product Distributed Qty 23 units
Reason For Recall It was found that in vHP scan, the estimated DLP (total exposure dose of all scans in a single examination) value displayed in the eXam Plan window in scan planning and the DLP value displayed in the summary after scanning are incorrect.

Event Detail

Event Id 64667
Product Type Devices
Status Terminated
Recalling Firm Toshiba American Medical Systems Inc
City Tustin
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-11-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including the states of WA, OH, CA, TX, WV, IL, AZ, CA, WI, ME, WI, NC, FL, MT, and HI.