BEUDAMED
    FDA Recall Terminated

    OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.

    Recall: Z-1207-2019 · Initiated March 19, 2019

    Recall

    Recall Number
    Z-1207-2019
    Event Number
    82491
    Firm
    Carestream Health, Inc.
    FEI Number
    1317307
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 19, 2019
    Terminated
    April 27, 2020
    Address
    1049 W Ridge Rd, Rochester, NY, 14615-2731

    Description

    OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.

    Reason

    When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.

    Action

    Carestream issued a "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 15, 2019 on March 19, 2019 via USPS Certified Mail Return Receipt Requested, describing problem, risk to health and corrective action. Carestreams representative will contact to schedule a convenient date and time within the next 6 months to install the software update. In the meantime, please use extreme caution to ensure proper reassignment of both parent and companion volumes whenever reassignment to a different patient is required. Also complete and return the Consignee Notification Acknowledgement form by e-mail to: [email protected]. If you have distributed the device outside your facility, please alert your customer(s) of this field correction and contact the Carestream Customer Care Center as instructed above. Questions or concerns, contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call the local Carestream Service support number.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: Arizona, California, New York, Alabama, Georgia, Georgia, Illinois, Minnesota, New York, Oregon, Pennsylvania; and countries of: IRAN, ITALY, JERUSALEM, KOREA, PHILIPPINES, PORTUGAL,SAUDI ARABIA, SINGAPORE, SWITZERLAND THAILAND, and UNITED KINGDOM.

    Quantity

    37 units