Events

Recall of Device Recall GE Healthcare, Discovery IGS 730 & Discovery IGS 740

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
    70073
  • Event Risk Class
    Class 2
  • Event Number
    Z-0966-2015
  • Event Initiated Date
    2014-12-10
  • Event Date Posted
    2015-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132213
  • 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 unintentional system motion or rotation due to a positioning user interface issue with discovery igs 730 and 740 products.
  • Action
    Consignees were sent a 12/10/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 12223 dated December 10, 2014. 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 ( US call 800-437-1171, other countries contact your local GE Healthcare Service Representative).

Device

Device Recall GE Healthcare, Discovery IGS 730 & Discovery IGS 740
  • Model / Serial
    Mfg Lot or Serial # System ID 0000013C2A0001 203694IGS730 0000011C2A0005 610954OR1 0000014A2A0009 718283D740 0000014A2A0007 SO4208228 0000014A2A0016 SO4242294 0000014A2A0004 206VMDISCOVERY1 Not available 330375HOR 0000014A2A0006 190020RX26 Not available 190059RX30 Not available SO4165355 Not available 82416120043 Not available 82416040061 00000011C2A003 A4185526 0000012C2A0002 M4160476 0000014A2A0008 S41600101 00000612802BU9 M54866AG1 Not available M40480222 Not available HC4348XR11 0000014A2A0001 YV2000 Not available XR649425BU6 Not available SO4239583 Not available AE1477RX04 0000013A2A0003 00169VAS01 0000013A2A0002 10692VAS01
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-Distributed in the states of CO, CT, MS, NJ, NY, OH, and WA, and the countries of BELGIUM, CANADA, CHINA, FRANCE, GERMANY, JAPAN, MEXICO, PERU, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    GE Healthcare, Discovery IGS 730 & Discovery IGS 740. || Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. || Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.
  • 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