Events

Recall of Device Recall GE Innova

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

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
    45845
  • Event Risk Class
    Class 2
  • Event Number
    Z-0691-2008
  • Event Initiated Date
    2007-11-15
  • Event Date Posted
    2008-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66259
  • 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
    Digital Fluoroscopic Imaging System - Product Code MQB
  • Reason
    Frozen image problems: during an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the dl (digital leader acquisition system) live monitor screen. in such cases, the system continued to send out x-rays without reporting an error message. the result was that the live imaging screen displayed an older "frozen" image until the operator released the.
  • Action
    Customers were contacted by means of an Urgent Medical Device Correction Letter on November 9, 2007. The letter described the product and the safety issue. The letter also made short term recommendations and described a long term solution, which is pending as an expected hardware and/or software modification that will be made at no cost. Short Term Recommendation: Take extra care when working with motionless anatomy or devices where there is little evident motion to warn you of the frozen image occurrence. Always completely shut down and restart the system (not just reset) immediately after such an error occurs. Also, please immediately report this issue to your local GE Healthcare field service engineer.

Device

Device Recall GE Innova
  • Model / Serial
    HU1099VA04 0850060719 0850060724 0850060726 0850060727 0850060728 378INV31 0910064009 0910163012 0910163013 0910163015 BE5003VA02 140024RX09 BA4080VA01 2573329 2667313 BG4549VA02 082416040018 082416140004 082416290001 082416140003 082416130018 082416080001 082416010006 082416020004 082416020005 082416030006 082416040015 082416040019 082416100013 082416110002 082416110003 082416120010 082416140002 082416150001 082416160008 082416160009 082416160013 082416180004 082416190004 082416190001 082416190002 082416190003 082416210006 082416210008 082416220008 082416270002 082416300001 082416310003 082416310006 082449100050 082416160011 082416160012 082416170002 082416040017 082416070004 2625365INNOVA 2645993INNOVA CS1006VA03 0002655786 M2030709 M4163030 M4166988 M5480755 M6083613 A6017504 GE1005VA01 HC4348XR01 HC1536XR04 00203VAS01 01367VAS02 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001 B5810907 YV0036 YV0162 YV0048 YV0163 XF0250 YV0033 YV0034 YV0035 YV0038 YV0039 YV0040 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 YV0049 YV0050 YV0051 KW1055VA01 0834160003 83INNOVA1188379 0920169007 2048000INNOVA 2664627INNOVA PL1082VA01 600098VA01 RU2457VA01 RU1482VA02 RU1475VA01 RU1550VA01 MPX82206 FPG86403 FPG93008 DPM32143 DPN88402 0853060194 01012VAS01 41018VAS01 58002VAS01 60001VAS01 215576INNOVA1 518525LAB1 760242CATH1 404686CRI3 4103623100 281420LAB23100 541382CV3 205783BCL5 540953INNOVA 2035763100 508941IN1 717217INN31 843797TCL2 573815BCR1 361980INNOVA2 214590PH3100 313593IC2 561266IN31 303629CL4 303629EP 3027443100 7018573100 303788CL2 812450EP1 239939CLA 850862IN3100 352333CATH1 352333CATH2 8184093100 919731WMINOV 305364P3100 205877CCL1 808547QCV2A 281440CL3 208227CATH2 2014183100 7028533100 865693CCL1 765453INNOVA1 609757IN3100 6619483100 219326IN31 7022333100 816969LSCATH 209334LINNOVA1 310319SM3100 502587LAB1 219877IN31 9734293100 215335INNOVA1 239436CATH3 239513CRLAB1 8053703100 615222H 812858GWLAB1 812858GWLAB2 8014793100 270688INN 65049331 850747BR3100 6106483100 8508573100 850469BCV1 8508573100 ECXV1406C 413447CATH BPINNOVA3R 207662CL4 207879CL131 770991CL3 951788INNOVA3 951788INNOVA2 541677MINNOVA1 5033703100 417269SCLD 7278253100 253968INNOVA 254742KDCL1 662377CV4 412437INNOVA 9202623100 8019643100 303425CL4 2197573100 0002595303 228818VASC 316651INNOVA31 316962WCVC1 316962WCVC2 325428CATH1 325428CATH3 336832MCPV 360456XCL3 361857CATH1 405272SCL2 405372S3100 405604D3100 405840OIC3100 406447VAIN3 406543IN3 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 502852INNOVA 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 516663INNOVA1A 530244XC106 561548CL4 570476INNOVA31 573458CL1 573632CRC2 6012883100CV2 603421PCL 610595CL1 610770INNOVA31 610983INNOVA1 616392INNOVA 617732IN9 618241GSI3100 620225INNOVA31 631968INNOVA2 631968INNOVA3 662377CV2 671GMHAINVA 708WESTSUB3100 713359INC 713948INA 717782INNOVA31A 718245UNITY 718470INNOVA2 718780CATH2 732776CATH6 770991CL1 772LWCL1 775982CATH2 781340IN2 803255CL1 804285CATH1 814676C1 815344CARDIAC3 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816985NKCI 847362CONCATH4 856596IN3100 864255SFCL3 901516R3 903UT3100 904276CTH1 909464IN3 909825VAINNOVA 910343NHIN4 913345MI1 940626DCH3100 954987CCL9 956698INN31 970350CL1 970945CL1 973877LAB4 ECXV1406B FHORLCL7 580548B3100 941798CLAB2 760323DRINNOVA 718270INNOVA1 603580ECL1 410740CV MARTINSVILLE310 480728LAB2 865481CCL2 405610NW3100 8157413100 251633PROV 907562CATH1 919784REP1 601883CL1 650369SV3 610954INNOVA1 760242CATH2 314768SMCL1A 2035763100A 402559UCB 561694IN1 2036883100 and 388567772VASMET
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA including states of AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, SC, TN, TX, WA, WI, AK, AL, AZ, ,CT, DE, HI, ID, KS, KY, ME, MI, MN, MS, MT, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, UT, VA, WV, and Puerto Rico and countries of Hungary, Korea, Algeria, Argentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Finland, France, Georgia, Germany, Great Britain, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Morocco, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Singapore, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Turkey, and Venezuela.
  • Product Description
    GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
  • Manufacturer
    GE Healthcare

Manufacturer

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