Events

Recall of GE Healthcare, Discovery IGS 730.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical 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
    73968
  • Event Risk Class
    Class 2
  • Event Number
    Z-1706-2016
  • Event Initiated Date
    2016-04-15
  • Event Date Posted
    2016-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145778
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    Potential non-recoverable loss of image acquisition. the affected discovery systems may experience multiple x-ray abort errors before or during a real-time fluoroscopic interventional procedure.
  • Action
    Consignees were sent on 4/15/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12246 dated April 14, 2016. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

GE Healthcare, Discovery IGS 730.
  • Model / Serial
    Mfg Lot or Serial # System ID 664365BU4 804828CATH4 669085BU3 573815D730 668484BU9 714FVDISC 672437BU1 775770CATHLAB3 0000HXF3001331 801714DIS730 00000632172BU3 203694IGS730 00000633128BU4 309624FT6 00000633831BU3 619532DISCOVERY 00000630288BU9 303426IR 0000HXF3001333 949250DISC730 00000637023BU3 214345IGS730 0000HXE9001300 650723SC1 00000646169BU3 330375HOR 00000638611BU4 414649DIS1 00000646917BU5 720854IGS730 00000614688BU0 610954OR1 00000622054BU5 423778DISC 646007BU5 206VMDISCOVERY1 00000637724BU6 281BAYIGS730 Not Avaialble GON4345699 Not Avaialble GON4110095 Not Avaialble DZ1104VA03 00000661681BU7 030078RX05 00000651337BU8 190059RX30 00000659126BU7 210060RX14 0000HXE9001292 613722D730 00000650197BU7 082416040061 00000653093BU5 082416040069 00000668482BU3 082416040074 Not Avaialble 082416060019 00000653092BU7 082416100080 00000651999BU5 082416120043 Not Avaialble 082416200019 00000618688BU6 M54866AG1 00000614687BU2 A4185526 0000013A2A0001 M40480222 00000623224BU3 M4160476 00000663234BU3 M94838145 00000646918BU3 S41600101 00000650095BU3 HC4348XR11 00000671395BU2 HC4348XR14 00000660146BU2 HU1205VA03 00000627794BU1 IE1147VA01 00000672728BU3 B5120737 00000642198BU6 YV2000 BAPFI0033-0011 XV649425BU6 00000653091BU9 XVE14287001 Not Avaialble SA2454VA01 00000615500BU6 0847160010 0000014A2A0010 AE1477VA01 Not Avaialble GON4316421 00000642197BU8 10692VAS01 00000638812BU8 00169VAS01 Not Avaialble 00584VAS06
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA, BELGIUM CANADA, CHINA, FRANCE, GERMANY, HUNGARY, IRELAND, ITALY, JAPAN, MEXICO, NETHERLANDS, PERU, SAUDI ARABIA, SINGAPORE, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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