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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 64674
Product Type Devices
Status Terminated
Recalling Firm Toshiba American Medical Systems Inc
City Tustin
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-08
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern USA nationwide. No international.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. 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 ÿ30 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 ÿ55 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 ÿ81 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 Class II 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. 95 units Z-0994-2013
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