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U.S. Department of Health and Human Services

Class 2 Device Recall DRAD3000E Radrexi Xray System

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  Class 2 Device Recall DRAD3000E Radrexi Xray System see related information
Date Initiated by Firm December 29, 2011
Date Posted February 02, 2012
Recall Status1 Terminated 3 on March 24, 2014
Recall Number Z-0941-2012
Recall Event ID 61010
510(K)Number K083503  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***"
Code Information Lot number is not utilized. Serial numbers of the following:  U2A0892009, U2A08X2010, U2A08X2011, U2A08Y2012, U2A08Z2013, U2A08Z2014, U2A0912015, U2A0912016, U2A0922017, U2A0942019, U2A0942020, U2A0942021, U2A0952022, U2A0952023, U2A0972024, U2A0972025, U2A0982026, U2B09X2027, U2B09Y2028, U2B09Y2029,  U2B09Z2030, U2B1042031, U2B1042032, U2C1052033, U2C1062034, U4A0982001, U4A0982002, U4A0992003, U4A09X2004, U4A09Z2005, U4A09Z2006, U4A09Z2007, U4A1022009, U4B1022010, U4B1032011, U4B1052012, U4B1052013, U4B1062014, U6A0972001 and U4B1012008. 
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		 It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recall notification titled "URGENT: MEDICAL DEVICE CORRECTION", was sent on 12/29/11 to customers via certified mail. The letter informed the customer of an issue with the starter cable used for high speed rotation on the Radrex X-Ray System. The letter also informs customers of the corrective measures: a replacement cable will be installed on your system to prevent this issue from occurring. An 800 number was provided for any questions regarding the letter.
Quantity in Commerce 39
Distribution Class II Recall - Nationwide Distribution (USA) - Including the states of VA, IL, CA, PA, TN, OH, LA, TX, OK, AR, AZ, MS, WV, TN, WI, NJ, MN, NY, IA, FL, and Washington D.C.
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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