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U.S. Department of Health and Human Services

Class 2 Device Recall TSXIOI: AQUILION 32/64; System

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 Class 2 Device Recall TSXIOI: AQUILION 32/64; System see related information
Date Posted April 08, 2013
Recall Status1 Terminated on June 17, 2013
Recall Number Z-1067-2013
Recall Event ID 64667
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed.

Designed to produce cross-sectional images of a human body.
Code Information 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

Recalling Firm/
Manufacturer
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92780-7047
714-730-5000
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall
The firm initiated this recall due to a potential software issue. The DLP (Dose Length Product) value may be displayed incorrectly when the vHP option is used.
FDA Determined
Cause 2
Process design
Action Toshiba sent "URGENT: MEDICAL DEVICE CORRECTION" letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter contained a return reply form that is to be faxed to TAMS for retention. Contact the firm at (800) 421-1968 for questions relating to this letter.
Quantity in Commerce 23 units
Distribution Nationwide Distribution including the states of WA, OH, CA, TX, WV, IL, AZ, CA, WI, ME, WI, NC, FL, MT, and HI.
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.
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