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U.S. Department of Health and Human Services

Class 2 Device Recall Toshiba Infinixi XRay System

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  Class 2 Device Recall Toshiba Infinixi XRay System see related information
Date Initiated by Firm November 08, 2012
Date Posted March 25, 2013
Recall Status1 Terminated 3 on March 26, 2013
Recall Number Z-0994-2013
Recall Event ID 64674
510(K)Number K120073  K113052  K081624  K052884  
Product Classification x-ray system - Product Code MQB
Product Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
Code Information NO. SERIAL NO. LASTFOUR MANUFACTURE DATE  1 A3SS2014 2014 MAY 2003  2 UVBlOS2001 2001 MAY 2010  3 USC1062001 2001 JUNE 2010  4 U4A09X2002 2002 OctOBER 2009  5 U4A09Y2003 2003 NOVEMBER 2009  6 U4A10X2006 2006 OctOBER 2010  7 UEA1072003 2003 JULY 2010  8 UDA09X2002 X2002 SEPTEMBER 2009  9 UCA1092005 2005 SEPTEMBER 2010  10 U4B0992006 2006 SEPTEMBER 2009  11 U4A1012004 2004 JANUARY 2010  12 UCA10S2006 2006 MAY 2010  13 UEA09Y2002 2002 NOVEMBER 2009  14 W2A1012082 2082 JANUARY 2010  15 W1C0652303 2303 MAY 2006  16 UDA0952001 2001 MAY 2009  17 UDA0952002 2002 MAY 2009  18 UUA1042011 2011 APRil 2010  19 UCA1022003 2003 FEBRUARY 2010  20 UKA1022007 2007 FEBRUARY 2010  21 U4B1062007 2007 JUNE 2010  22 A3592048 2048 SEPTEMBER 2003  23 UDA09Z2005 2005 DECEMBER 2009  24 UUA09Y2004 2004 NOVEMBER 2009  25 UUA09Y2005 2005 NOVEMBER 2009  26 U6A0992002 2002 SEPTEMBER 2009  27 W1D07Z2456 2456 DECEMBER 2007  28 U4A1042005 2005 APRil 2010  29 UUA1052012 2012 MAY 2010  ¿30 U7BlOS2001 2001 MAY 2010  31 UKA09Z2005 2005 DECEMBER 2009  32 A3S32005 2005 MARCH 2003  33 UCA1062007 2007 JUNE 2010  34 UTA1092003 2003 SEPTEMBER 2010  35 UCA09Z2002 2002 DECEMBER 2009  36 U6A1072009 2009 JULY 2010  37 U4B0982005 2005 AUGUST 2009  38 U4B0972004 2004 JULY2009  39 W1D0752394 2394 MAY 2007  40 UFB1042002 2002 APRil 2010  41 UDB1072007 2007 JULY 2010  42 UCA0972001 2001 JULY 2009  43 UCA0972001 2001 JULY 2009  44 W1D0722373 2373 FEBRUARY 2007  45 U6A1062008 2008 JUNE 2010  46 U6A103200S 2005 MARCH 2010  47 UCA1072004 2004 JULY 1010  48 UTA1062002 2002 JUNE 2010  49 W1D0732380 2380 MARCH 2007  50 A3622065 2065 FEBRUARY 2003  51 A3622066 2066 FEBRUARY 2003  52 UDA0962001 2001 JUNE 2009  53 UUA0982001 2001 AUGUST 2009  54 UKA1042008 2008 APRil 2010  ¿55 UKA1082011 2011 AUGUST 20010  56 U4A08Y2001 2001 NOVEMBER 2008  57 U4A0922002 2002 FEBRUARY 2009  58 U6A0972001 2001 JULY 2009  59 U6A1012003 2003 JANUARY 2010  60 UCA1022004 2004 FEBRUARY 2010  61 UKA09Y2004 2004 NOVEMBER 2009  62 U4B0962003 2003 JUNE 2009  63 U6AlOS2007 2007 MAY 2010  64 UKA09Z2006 2006 DECEMBER 2009  65 U6A1042006 2006 APRil 2010  66 UKA1052009 2009 MAY 2010  67 UKA1072010 2010 JULY 2010  68 UUA09X2003 2003 OCTOBER 2009  69 U6A1022004 2004 FEBRUARY 2010  70 U4A0972001 2001 JULY 2009  71 UUA1042010 2010 APRI12010  73 W1D0842501 2501 APRil 2008  73 UKA0962002 2002 JUNE 2009  74 UEA0982001 2001 AUGUST 2009  75 UDBlO72008 2008 JULY 2010  76 UUA1012008 2008 JANUARY 2010  77 UUA1012009 2009 JANUARY 2010  78 UUA1062013 2013 JUNE 2010  79 UCA1032005 2005 MARCH 2010  80 UCA09Z2002 2002 DECEMBER 2009  ¿81 W2A09Y2064 2064 NOVEMBER 2009  82 UUA1092014 2014 SEPTEMBER 2010  83 U4BlO72009 2009 JULY 2010  84 UUA09Z2006 2006 DECEMBER 2009  85 UUA09Z20D7 2007 DECEMBER 2009  86 UDA09Z2004 2004 DECEMBER 2009  87 UDA09Y2004 2004 NOVEMBER 2009  88 UTA1062001 2001 JUNE 2010  89 UCA1012003 2003 JANUARY 2010  90 UKA0962001 2001 JUNE 2009  91 UUA09820D2 2002 AUGUST 2009  92 UKA0982003 2003 AUGUST 2009  93 UDA1012006 2006 JANUARY 2010  94 UCA1072008 2008 JULY 2010  95 UDA09Y2003 2003 NOVEMBER 2009  
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.
FDA Determined
Cause 2		 Software design
Action In November, 2012, Toshiba America Medical Systems, Inc. sent an Urgent: Medical Device Correction letter to customers. The letter contains a return reply form that is to be faxed to TAMS for retention.
Quantity in Commerce 95 units
Distribution USA nationwide. No international.
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.
510(K)s with Product Code = MQB and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION
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