Events

Recall of Device Recall GE Healthcare Innova

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Med Systems 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
    37775
  • Event Risk Class
    Class 2
  • Event Number
    Z-0913-2007
  • Event Initiated Date
    2007-02-05
  • Event Date Posted
    2007-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51504
  • 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 - Product Code MQB
  • Reason
    Unintended gantry movements : ge healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic smart box controller, that may impact patient or staff safely.
  • Action
    Consignees were contacted via a letter "Urgent: Safety Notice" dated 2/5/07. The letter described the safety issue, affected product, safety instructions and product correction contact information. -This is the short-term fix, GE is working on a correction that will be installed at each site as the long term correction

Device

Device Recall GE Healthcare Innova
  • Model / Serial
    65049321 2035762100 4436432100 0002600531A 0002628342A 208227CATH1 208367INNOVA 212305CATH1 215453INNOVA21 217383CCL2A 219932DCL2 229228INNOV21C 239436CATH4 251435ICV3 262255INNOVA2 303425CL3 303788CL1 303839CL2 304424INNOVA 305364P2100 305682IN2 308865GIN1 317355INNOVA3 318448CA1000 330363LAB3 330375LAB2 360456XCL4 405604D2100 408559INV1 410337INNOVA6 414447CA1 414649INNOVA2 417347FCV4 501257VALAB1 508856IN21 516562INNOVA6 516562INNOVA7 518243LAB1 518243LAB2 541732CV2 570476INNOVA21 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1 610250INNOVA1 610250INNOVA3 610776INNOVA21 615446CV1 617636CL1 630856H2100 650369SV4 651582IN3 661327INNOVA1 713375U2100 713375UCA 713794LAB1 717217CA10002 717217INN21 717544GECATH2 717544GECATH3 718470EP 727869CATH3 727942CATH2 732324INN1 732923INN 770HMCCL1 781340IN3 785354HRTEP 804764CATH2 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 815741CA1000 817329BG2100 843724CL1 843724CL2 843724CL3 845365V13 845368CATH1 858554INNOVA2 901765EP 910343EP1 910343EP2 910671CICR 910671INOV21 954987CCL7 954987CCL8 970350CL2 973579LAB1 985898INNOVAB BGRPWSCA01 CM2100 00060VAS02 00159VAS04 00192VAS04 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 35021VAS02 468668XR01 58010VAS01 600042VA03 A004RX01 A4166952 A5125125 A5164510 A5624112 A5807919 B1650215 C5123625 C5123626 DK1066VA02 DZ1006VA01 H17654VAS8 H2077VAS27 HC4355XR06 HU1094VA01 M1334109 M2068110 M2569315 M2844529 M4198195 M4200108 M4211066 MA1004VA02 NO1009VA03 PC0052XR07 PC0052XR08 SA1011VA01 SA1054VA02 SY1001VA02 cee15663 416480INNOVA 604682INNOVA2 835160018 850060723 910162009 910162010 910162011 910162012 910163011 83016862101656 082416030004 082416040011 082416040012 082416070006 082416100012 082416120008 082416120009 082416130016 082416130019 082416130024 082416200004 082416220010 83016002101586 83016102100795 83016202101036 83016242100936 83016802100516 83016802100866 83016802100916 83016862101656 83016862101916 920169006 YV0054 YV0055 YV0056 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068 YV0070 YV0071 YV0072 YV0073 YV0077 YV0080 YX1483
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- USA including states of WV, WI, WA, VA, UT, TX, TN, SD, SC, PA, OR, OK,OH, NY, NV, NJ, NE, NC, MT, MO, MN, MI, ME, MD, MA, LA, KY, KS, IN, IL, ID, HI, GU, GA, FL, DE, CT, CO, CA, AZ, AL, AK and countries of UNITED KINGDOM, TURKEY, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SAUDI ARABIA, RUSSIA, POLAND, NORWAY, NEW ZEALAND, THE NETHERLANDS, MOROCCO, MALAYSIA, KOREA, JORDAN, JAPAN, ITALY, ISREAL, IRELAND, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, FINLAND , DENMARK, CZECH REPUBLIC, CHINA, CANADA, BELGIUM, AUSTRALIA, and ALGERIA.
  • Product Description
    GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular imaging system.).
  • Manufacturer
    General Electric Med Systems LLC

Manufacturer

General Electric Med Systems LLC
  • Manufacturer Address
    General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA