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U.S. Department of Health and Human Services

Class 2 Device Recall RadrexI DRAD3000E;

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  Class 2 Device Recall RadrexI DRAD3000E; see related information
Date Initiated by Firm May 22, 2009
Date Posted March 22, 2010
Recall Status1 Terminated 3 on March 21, 2012
Recall Number Z-1177-2010
Recall Event ID 52816
510(K)Number K073165  
Product Classification Solid State X-Ray Imager - Product Code MQB
Product Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system
Code Information Serial Numbers: U2A0872007, U2A08Y2012, U2A08Z2014, U2A0892009, U2A08Z2013, U2A0912016, U2A08X2010, U2A08X2011, U2A0862006, U2A0832002, U2B0852005, U2A0832001, U2B0842003, U2A0942019, U2A0942020, U2A0942021, U2A0942017, and  U2A0882008.
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system due to a software bug that results in a loss of image.
FDA Determined
Cause 2		 Component design/selection
Action An Urgent - Medical Device Correction letter was sent to customers. The letter described the issue, the corrective action, and the avoidance. Toshiba America Medical Systems informed customers that software was being prepared to address the issue and planned to send representatives to each customer affected by the field correction to provide a software upgrade to the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system. Customers were to complete the attached customer reply form. Questions were to be directed to Aaron Ybarra, X-ray Product Manager at 800-421-1968, ext. 2492.
Quantity in Commerce 20
Distribution Nationwide Distribution -- Including states of PA, VA, OH, TN, LA, IL, CA, MT, AZ, and TX.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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