BEUDAMED
    FDA Recall Terminated

    All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 Model 100580 SGL Trolley, Serial No.''s less than TRS962633 Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.

    Recall: Z-0589-04 · Initiated February 19, 2004

    Recall

    Recall Number
    Z-0589-04
    Event Number
    28229
    Firm
    Burton Medical Products Corp
    FEI Number
    2018492
    Product Code
    KZF
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 19, 2004
    Posted
    July 20, 2004
    Terminated
    January 25, 2012
    Address
    21100 Lassen St, Chatsworth, CA, 91311-4250

    Description

    All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 Model 100580 SGL Trolley, Serial No.''s less than TRS962633 Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.

    Reason

    Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.

    Action

    Firm will ask for subdistribution information from thier distributors via letter on 1/30/2004. Letters will be sent directly to users. Firm will retrofit all sites with suspect units with new pivot assemblies.

    Distribution

    Nationwide.

    Quantity

    17,000 estimated