BEUDAMED
    FDA Recall Terminated

    Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512.

    Recall: Z-0738-2007 · Initiated March 6, 2007

    Recall

    Recall Number
    Z-0738-2007
    Event Number
    38233
    Firm
    Carestream Health, Inc.
    FEI Number
    1317307
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 6, 2007
    Posted
    June 30, 2007
    Terminated
    June 29, 2007
    Address
    1049 West Ridge Road, Rochester, NY, 14615

    Description

    Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512.

    Reason

    The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).

    Action

    On 2/21/07, Eastman Kodak notified CDRH of its proposed Corrective Action Plan CAP). The CAP was approved by CDRH under the following conditions: (1) Kodak will visit each user facility, and apply dial indicator labels to the collimator knobs, apply a field size label to the collimator housing, and verify that each system complies with the field indication performance standard. (2) Kodak will prepare adequate instructions for the assembly/installation and testing of the dial indicators labels and field size labels. These instructions are to be furnished to all owners of the Kodak Direct View DR 7500 Systems. (3) Kodak will supplement the Kodak DR 7500 system product report with a copy of the adequate instructions. (4) Kodak will perform 100% verification of the recall effectiveness. (5) Kodak will not charge for the corrections and will reimburse the owner for any out-of-pocket expenses. (6) Kodak will notify the manufacturer of the Ralco 302 ACS collimators, Ralco, that the collimator is noncompliant with the performance standard. Kodak has reported that the CAP was completed as of 5/07/07.

    Distribution

    Nationwide: CO, IL, MI, MN, MS, NY, OK, PA, SC, TN, WA

    Quantity

    Domestic: 28 units