BEUDAMED
    FDA Enforcement Class II Terminated

    Discovery IGS 730 Interventional Fluoroscopic X-ray Systems

    Recall: Z-2386-2018 · Reported July 18, 2018

    Enforcement

    Recall Number
    Z-2386-2018
    Event ID
    80177
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Medical Systems, SCS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2018
    Initiation Date
    March 29, 2018
    Classification Date
    July 6, 2018
    Termination Date
    June 15, 2021
    Address
    283 rue de la Miniere, Buc, N/A, France

    Description

    Discovery IGS 730 Interventional Fluoroscopic X-ray Systems

    Reason

    The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.

    Code Info

    Model Number 5730890, Serial Numbers (System ID): 00000D3-17-030 (904BHHCHY), 00000D3-17-032 (083172440628), 661327IGS730 (00000D3-18-001), GON4598369 (00000D3-18-004), 082416140028 (00000D3-17-025), M4234253 (00000D3-17-028), YV3601 (00000D3-18-005), 6073XR0058 (00000D3-17-031).

    Distribution

    US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution: Argentina, Brazil, China, Colombia, Egypt, France, India, Indonesia, Iran, Italy, Japan, Kuwait, Lithuania, Myanmar, Palestine, Poland, Russia, Saudi Arabia, Singapore, Spain, Tunisia, Turkey, United Kingdom, Vietnam.

    Quantity

    102 devices total