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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmNovember 10, 2005
Date PostedDecember 23, 2005
Recall Status1 Terminated 3 on February 05, 2007
Recall NumberZ-0324-06
Recall Event ID 34091
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
ProductDigital Radiography System Model DFP8000D
Code Information Serial Numbers: A3622068 A4512074 A3582042 A3542012 A4512073 A3552017 A4552098 A3622065  A3622066 A4542090 A3592048 B4602125 B4612134 B5512155 B4582116 W1B0542168 A3572018 A4562102 A35B2041 B4612132 A3542011 A3582037 A3622069 B4622149 B4602129 A3542006 B4612133 A3572032 A3522002 B4622146 A3542008 A3602050 A4512076 A4522079 A4522081  B4622150 B5522162 A3592046 A3532005 A3612057 A4572109 A3517002 B4622148 A4562099 A3612061 A4562101 B4612137 A3602055 A4542092 B5512154 A4542088 A3572030 A3582035 A3522004 A3562022 A3582036 B4622151 A3582013 A3582013 A45721 07 B4612141 A3517003 A4522080 A3522001 W180542173 
Recalling Firm/
Manufacturer		 Toshiba American Med Sys Inc
2441 Michelle Dr
Tustin CA 92781
For Additional Information ContactPaul Biggins
714-730-5000
Manufacturer Reason
for Recall		To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost.
FDA Determined
Cause 2		Other
ActionAn Advisory Letter was sent to the customers via certified mail. Toshiba issued a Field Modification Instruction (FMI XRA29-90828) to correct that software bug and bring the DFP-8000D into compliance. The FMI is provided to the customers at no charge.
Quantity in Commerce72
DistributionNationwide
Total Product Life CycleTPLC 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.
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