BEUDAMED
    FDA Recall Terminated

    Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

    Recall: Z-0001-2008 · Initiated July 26, 2007

    Recall

    Recall Number
    Z-0001-2008
    Event Number
    38473
    Firm
    Bio-Logic Systems Corp
    FEI Number
    1419887
    Product Code
    GWQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 26, 2007
    Posted
    November 3, 2007
    Terminated
    August 12, 2009
    Address
    1 Bio Logic Plaza, Mundelein, IL, 60060-3708

    Description

    Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

    Reason

    Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.

    Action

    Bio-logic sent a Safety Alert letters dated 7/26/07 to the affected customers, warning them that using the pole to transport the cart may cause the weld at the base of the pole to weaken, causing it to break. As a precaution to ensure customer safety, the accounts were instructed to place the enclosed red sticker on the pole, below the tightening knob. An Instruction sheet is enclosed . The warning label reads: "Caution: Do not use as a handle to move cart. Always lower camera when transporting. Avoid sudden stops or collisions." The accounts were requested to complete and return an enclosed reply sheet acknowledging the receipt of the letter and the placement of the warning labels on the poles. Any questions were directed to Customer Support at 1-800-332-3114.

    Distribution

    Worldwide Distribution -- USA and China, Egypt, Hong Kong, Israel, Malaysia and Saudi Arabia

    Quantity

    311 units