BEUDAMED
    FDA Recall Open, Classified

    Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

    Recall: Z-1342-2022 · Initiated May 20, 2022

    Recall

    Recall Number
    Z-1342-2022
    Event Number
    90401
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 20, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

    Reason

    During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.

    Action

    On May 20, 2022, the firm sent Urgent Medical Device Correction letters to affected customers. Customers were informed that in the event this issue occurs, the system will switch to Bypass fluoroscopy mode. In Bypass fluoroscopy mode a limited imaging functionality (non-subtracted, continuous fluoroscopy with reduced power and without acquisition and storage of images) would remain available. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Customer Instructions: In the event you recognize a high squeaking scratching loud noise out of one of the system cabinets, please contact your service partner for immediate action. It is recommended to avoid performing any critical interventions on the system. Due to the possible risk of electrical shock to the technician, please ensure that your service partner (if not Siemens Healthineers) first contacts Siemens Healthineers' service organization before starting any corrective actions. The firm will replace the affected parts. The service organization will contact customers to arrange a date to perform the corrective action. To schedule an earlier appointment, contact the firm at 1-800-888-7436.

    Distribution

    Domestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WI and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Japan, Kazakhstan, Netherlands, New Zealand, Norway, Oman, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    195 worldwide, 88 US