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Class 2 Device Recall RadrexI DRAD3000E; |
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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
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Product Classification |
Solid State X-Ray Imager - Product Code MQB
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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
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For Additional Information Contact |
714-730-5000
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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.
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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
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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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510(K) Database |
510(K)s with Product Code = MQB and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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