BEUDAMED
    FDA Recall Terminated

    Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); Distributed by and/or Manufactured by: Varian Medical Systems, Palo Alto, CA 94304.

    Recall: Z-1530-05 · Initiated March 30, 2005

    Recall

    Recall Number
    Z-1530-05
    Event Number
    31633
    Firm
    Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 30, 2005
    Posted
    September 9, 2005
    Terminated
    September 8, 2005

    Description

    Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); Distributed by and/or Manufactured by: Varian Medical Systems, Palo Alto, CA 94304.

    Reason

    Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated.

    Action

    On 3/16/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.

    Distribution

    US distribution is: CA, CT, IL, IN, KY, OH, MI, NC, NJ, NY, SC, TN, TX, VA, & WA, totaling 22 hospitals. Foreign distribution includes: Denmark, Hong Kong, and Japan. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers.

    Quantity

    24 units