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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
Recall Number Z-1163-2014
Classification Class II
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4103374100 00000461599BU3 410337INNOVA6 00000571721BU0 410368INNOVA1 00000442436BU2 4105434100 00000533867BU8 410554INNOVA1 00000548841BU6 410554INNOVA4 00000560325BU3 410614CV1 00000443912BU1 412623LAB3 00000454264BU3 419251LAB1 00000576989BU8 423493CL1 00000450075BU7 480821IN2 00000468193BU8 501257VALAB1 00000434782BU9 502587LAB4 FMI12204DUMM03 508383IN4100 00000581740BU8 509473RM1 00000459476BU8 5135844100 00000415698BU0 5136864100 00000479625BU6 516562INNOVA5A 00000460641BU4 516562INNOVA6 00000460969BU9 516562INNOVA7 00000441966BU9 516663INNOVA2 00000467462BU8 518525LAB1 00000467645BU8 540953INNOVA 00000513959BU7 570476INNOVA21 00000466830BU7 573256MHC 00000479758BU5 573815BCR2 00000433021BU3 573882UMC1 00000446439BU2 6012884100SP1 00000558894BU2 601376SP4100 00000437985BU5 6082634100 00000410733BU0 608324DAL 00000543076BU4 608775NOVA1 00000561529BU9 609267IN2100 00000546435BU9 609757IN3100 00000491706BU8 610250INNOVA3 00000442603BU7 614293LIBERTY2 00000563635BU2 614722INNOVA1 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00000460469BU0 845365V19 00000523086BU7 845368LAB1 00000544815BU4 850469BCV1 00000544202BU5 850747IN4100 00000485433BU7 856596IN3100 00000491032BU9 858554INNOVA2 00000422738BU5 8595724100 00000467881BU9 864255SF4100 00000548598BU2 864255SFCL2 00000537821BU1 865693CCL1 00000596870BU6 903CSM2121 00000458184BU9 903GS4100 00000454594BU3 904202CATH3 00000496915BU0 907562CATH1 00000436762BU9 918744JR4100 00000549261BU6 9284532100 00000442333BU1 9408984100 00000439384BU9 951788INNOVA4 00000545588BU6 954987CL4 00000482458BU7 954MW4100 00000430321BU0 956632INN4100 00000469847BU8 956698INN31 00000430322BU8 985867INNOVA2 00000514612BU1 COR359867 00000403215BU7 FWANG3217 00000580430BU7 2036884100B 00000590065BU9 303399EP 00000571259BU1 318449INNOVA3 00000057472BU0 352333CV3 00000590868BU6 361788CATH1 00000543267BU9 410337INNOVA2 00000590608BU6 412623H 00000480416BU7 423493I4100 00000594389BU9 541743OR15 00000436759BU5 614293LIBERTY1 00000590864BU5 615396EP 00000538571BU1 631968INNOVA2 00000425774BU7 650369SV5 00000589833BU3 770382CINN 00000465705BU2 904276CTH1 00000435786BU9 904276SP 00000476725BU7 910343EP1 00000612550BU4 973972LAB3 00000411137BU3 312792R4100 00000466829BU9 352333CATH1 00000444377BU6 757398INNOVA 00000444937BU7 77573841 00000437218BU1 4103323100 00000593466BU6 918OSUCATH2 00000453934BU2 417269SCLD 00000572422BU4 00052VAS04 00000467850BU4 378INV31 00000444914BU6 0910162006 00000464419BU1 0910163011 00000438629BU8 0910064007 00000417372BU0 250370INNOVA 00000429328BU8 416756INNOVA 00000491353BU9 514842AINNOVA 00000432687BU2 519685INNOVA 00000518369BU4 604682INNOVA1 00000537026BU7 604682INNOVA2 00000476531BU9 604875AINNOVA1 00000482420BU7 604875AINNOVA2 00000007C20329 905848INNOVA1 00000413716BU2 082406040022 00000600076BU4 082406070013 00000473100BU6 082416010005 00000501586BU2 082416040018 00000462912BU7 082416050002 00000585908BU7 082416090008 00000430320BU2 082416100006 00000461622BU3 082416100009 00000626767BU8 082416100065 00000446837BU7 082416120006 00000456458BU9 082416120007 00000459879BU3 082416140002 00000446285BU9 082416160005 00000480352BU4 082416160007 00000592459BU2 082416170004 00000461649BU6 082416200004 00000461008BU5 082416210004 00000559815BU6 082416210012 00000439906BU9 082416310003 00000544638BU0 082416310007 00000590598BU9 082416110007 00000446438BU4 082416130015 00000498661BU8 082416100012 00000424554BU4 082406120016 00000463449BU9 CS1006VA03 00000445594BU5 CS1054VA01 00000590862BU9 DK1066VA05 00000590866BU0 EG1843VA01 00000456800BU2 FI1015VA01 00000440111BU3 M2002624 00000438631BU4 M40480151 00000477885BU8 M4163030 00000000LS8-C1 R4211476 00000590317BU4 M4171816 00000412256BU0 407953XR01 00000465383BU8 HC4355XR06 00000576419BU6 HC4355XR07 00000514614BU7 HU1094VA01 00000582487BU5 083016102002169 00000467880BU1 083016102100795 00000590867BU8 083016860019010 00000501587BU0 IE1100VA01 00000476726BU5 A5605743 00000425390BU2 A5630803 00000594768BU4 A5195416 00000518355BU3 A5333037 00000608125BU1 A5365426 0000010C2M0154 A5401383 00000591390BU0 A5719853 0000010C2M0164 A5810824 00000463078BU6 A5697709 00000493966BU6 XF0153 00000564505BU6 YV0013 00000438669BU4 YV0022 00000439612BU3 YV0023 00000478097BU9 YV0035 00000547029BU9 YV0076 00000514380BU5 YX1483 00000459461BU0 YV0030 00000560738BU7 YV0363 00000612546BU2 YV0388 00000454589BU3 JO1000VA01 00000600863BU5 0850060744 00000560740BU3 0834160005 FMI12204DUMM01 28626INNOVA 00000445752BU9 477XVIN2553211 00000522945BU5 644INNOVA21 00000459368BU7 0920169006 00000435051BU8 NO1005VA05 0000009C2M0125 0843160016 00000476720BU8 600042VA02 00000441173BU2 787653INNOVA FMI12204DUMM02 RU1138VA01 00000551948BU3 RU3053VA01 00000418618BU5 SA1188VA03 00000589400BU1 MEX68922 0000010C2M0176 MEX68928 00000593472BU4 083016808780010 00000580432BU3 34078VAS01 00000537448BU3 60001VAS01 00000428165BU5 00171VAS01 00000462909BU3 00234VAS01 00000424824BU1 77137VAS01 00000483163BU2 00282VAS02
Product Distributed Qty 257(159 US, 98 OUS)
Reason For Recall GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue.

Event Detail

Event Id 67257
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MS, MO, NV, NJ, NY, NC, ND, OH, OK OR, PA, PR, RI, SC, TN, TX, UT, VA,WA,WY and WI., and the countries of ARGENTINA, AUSTRALIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PHILIPPINES, POLAND, RUSSIA, SAUDI ARABIA, SPAIN, SRI LANKA, TURKEY and UNITED KINGDOM.
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