Events

Recall of Device Recall Optima IGS 320

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
    72740
  • Event Risk Class
    Class 2
  • Event Number
    Z-0414-2016
  • Event Initiated Date
    2015-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142059
  • 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
    System, x-ray, angiographic - Product Code IZI
  • Reason
    Ge healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving optima cl323i & optima igs 320 systems.
  • Action
    GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#12237 dated November 13, 2015 to customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall Optima IGS 320
  • Model / Serial
    00000116342HL7 BA4020VA03 00000127265HL7 XVV1S15019 00000124734HL5 XV124857HL4 00000121103HL6 HC1251XR03 00000102618HL6 083016020038813 00000128170HL8 083016061894915 00000115935HL9 083016100119314 00000125802HL9 083016200031715 00000123471HL5 083016208011415 00000118232HL8 083016240028414 00000122806HL3 083016247131115 00000112586HL3 083016280008314 00000119769HL8 083016284903114 00000122805HL5 083016287138315 00000114746HL1 083016289336814 00000116996HL0 083016601010614 00000112287HL8 083016801002714 00000108901HL0 083016801024714 00000122417HL9 083016807113615 00000109262HL6 083016807511514 00000123932HL6 083016809698915 00000119571HL8 083016824740714 00000110467HL8 083016846514214 00000104227HL4 083016860037213 00000125616HL3 083016860528415 00000113585HL4 083016861004214 00000128059HL3 083016862769215 00000126960HL4 083016029472715 00000120518HL5 083016866085914 00000120528HL5 GON4260859 00000010594HL3 083016844488913 00000105944HL3 GON4144889 00000129362HL0 0004344218 00000122667HL9 5512XR0010 00000124068HL8 5512XR0032 00000124830HL1 5512XR0033 00000124904HL4 5512XR0025 00000125415HL0 5512XR0034 00000129237HL4 GON4344915 00000115056HL4 PL3480VA01 00000128693HL9 1573XR0032 00000121982HL3 42026VAS01
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AR, AZ, DC, FL, GA, IL, IN, LA, MI, NC, NE, NJ, NV, NY, OH, SC, TN, TX, WA. and the countries of Algeria, Bangladesh, Bosnia and Herzegovina, Brazil, China, Dominican Republic, Ethiopia, Georgia, Germany, India, Indonesia, Italy, Lebanon Martinique , Morocco, Poland, Republic of Moldova, Russia, Spain Thailand, Trinidad, Turkey, and Uzbekistan.
  • Product Description
    GE Healthcare Optima IGS 320. || Product Usage: || 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 non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
  • 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