Events

Recall of GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular Xray imaging systems.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62760
  • Event Risk Class
    Class 2
  • Event Number
    Z-2376-2012
  • Event Initiated Date
    2012-08-16
  • Event Date Posted
    2012-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111666
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    Ge healthcare has recently become aware of a potential safety issue with respect to the innova 2121iq & innova 3131iq systems. while performing a fluoroscopic acquisition with the innova 2121iq or innova 3131iq systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter dated August 16, 2012, to all affected consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, and Contact Information. Consignees were instructed that hospital staff should wait for Photo or Image to appear on the display (when store photo function is performed) before start of the next short duration fluoroscopy acquisition. For questions customers were instructed to call: United States (800) 437-1171 Japan: 0120 - 055 - 919 For other countries consignees should contact their local GE Healthcare Service Representative. For questions regarding this recall call 262-513-4122.

Device

GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular Xray imaging systems.
  • Model / Serial
    System ID (As required) 910162015 AZ4001VA01 BH1000VA01 BY4033VA01 BY4020VA02 BG4549VA01 BG4009VA01 416480INNOVA2 HSRINNOVA1 82416070010 82416150007 82416210022 82416040046 CS1006VA05 EG1000VA01 M4198064 N4192939 M4166990 M4212443 HC1819XR10 HC5284XR39 542120XR02 HC5284XR38 83016862100448 835160028 IQ1165VA02 IE1100VA03 A5632421 A5102694 A5379605 A5320145 B5114298 A5360408 YV0370 YV0365 YV0364 YV0166 YV0369 YV0473 YV0480 YV0478 YV0475 YV0362 YV0510 YV0474 YV0481 YV0367 YV0477 YV0388 YV0466 YV0500 YV0463 YV0476 YV0464 YV0462 YV0400 YV0366 YV0501 YV0520 YV0363 YV0555 YV0472 YV0471 YV0470 YV0469 YV0468 YV0467 KW1098VA01 KW1098VA02 KW1011VA02 LB1331VA01 LY1086VA01 834160006 834160005 834160004 INNOVA2948687 PL1804VA01 PER18124 RO1095VA01 RU3427VA01 RU2741VA04 RU3847VA01 RU3883VA01 NA SA2253VA01 SA2236VA01 847160005 847160006 850060744 850060739 MEX68922 853060209 853060201 853060200 853060198 853060202 856160010 AE1225VA01 00234VAS02 00095VAS08 05448VAS01 00440VAS04 10086VAS07 10307VAS01 00243VAS02 00026VAS01 256HHCIB1 205877CCL3 480512BP 8184093131 6263973131 415206IBP1X53 3108252121A 3108252121B 909LLUMC2121 661949INNOVA3 650493BIPL 510428BIPL 619543INNOVABP CHLDRNCL1 303436LCLP 303425CL2 2036882121 FHORLEP4 561548BIP 561495DLBIP FHORLEP5 FHORL3131 904202WCL1 561881BP1 561881BP2 808547QCV4 319272EP 208227INNOVA31 630856H3131 630933INVLAB4 309655FSP4A 773RES3131BP 309655FSP2B 219326EP1 812238UNBPL 317338PV4 317338CL4BP 2197383131 2192632121 2198362121 913541OP3131 316268BIPLANE 504842OMC3131 504842OMCEP2 504842OMCEP1 504897INNOVA2 985867INNOVA31 617636IN2121 857307IN12121 857307IN22121 617525IN13131 857307IN32121 410614CV2 410614CV1 4105502121 410740CV 3018912121 202782LABA 301295EP 301295CATH 616392BP 507385INN3131 612273INNOVA3 816698CP3131 816932SL3131 704355RM7 704355P2121 603650EP1 973971EP3 973972LAB3 7327762121 7323213131 505887CL1 7028533131 718579INNOVABP 516562INNOVA1 718226BP1 COR373252 COR373301 COR373295 ORMCIR2 518262BP1 5135843131 541743CL5 503OHSUCV4 503OHSUCV3 541743CL2 541382BP 570824BP1 215576INNOVA2 LVINOV6 610526LAB3 814877BP 215662INNOVA3 412623H 610954BP1 864512EPBP 843692GSBPEP 615284ANG2 615222BIH 615222BIG 615769SP1 956632INN3131 281637SL3131 832522MW3131 903CSM2121 817465AR3131 361857CATH2 VAD2121 BMANGIO 936539CL4 936WH2121 214590EP2121 BMEP 713794LAB8 832355LAB4 713794LAB11 281440BP31 210617VACATH1 MCDEP 801532LCA 540776LGVAS2 276258INV3131 434654CATH2121 253627INNOVA5 206598UWBP 253403CL4 509474BIP 509473RM1 4146492121 4144473131 ECXV1402B 304526INNOVABP YE1002VA01
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, HI, IK, IL IN, IA, KS, LA, MD, MA, MI, MN,MO, NV, NH, NH, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI,.and internationally to: AUSTRALIA, AZERBAIJIN, BAHRAIN, BELARUS, BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, JAPAN, KUWAIT, LEBANON, LIBYA, MALAYSIA, MEXICO, POLAND, PORTUGAL, ROMANIA, RUSSIA, SA¿DI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, and YEMEN.
  • Product Description
    GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. || K060259: 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. K061163: For Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices with Innova IVUS option: 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 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. Those devices are not intended for mammography applications. Innova IVUS Option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface, (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system. K091658: 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 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.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA