BEUDAMED
    FDA Recall Terminated

    Owandy Radiology I -MAX Touch 3D X-ray

    Recall: Z-0129-2016 · Initiated August 5, 2015

    Recall

    Recall Number
    Z-0129-2016
    Event Number
    71958
    Firm
    Villa Radiology Systems LLC
    FEI Number
    2243757
    Product Code
    OAS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 5, 2015
    Posted
    November 6, 2015
    Terminated
    March 22, 2017
    Address
    91 Willenbrock Rd, Ste B1, Oxford, CT, 06478-1036

    Description

    Owandy Radiology I -MAX Touch 3D X-ray

    Reason

    It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).

    Action

    Villa Radiology Systems Planned Action: 1. The current users manuals have been updated and addendums to the user manuals have been developed for currently installed Rotograph Evo 3D and Imax Touch 3D. The revisions and addendums contain all information required under 21 CFR 1020.33(c), 1020.33(d), 1020.33(g), and 1020.33(j). 2. New Rotograph Evo 3D and Imax Touch 3D systems will ship with the updated user manual. 3. Addendums will be provided to all end users CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22.

    Distribution

    US Distribution

    Quantity

    I-MAX Touch 3D- 6 installed