BEUDAMED
    FDA Enforcement Class II Terminated

    Zero-Gravity Radiation Protection System Radiology Personnel protective shield.

    Recall: Z-0080-2017 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0080-2017
    Event ID
    75240
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Contour Fabricators Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2016
    Initiation Date
    September 9, 2016
    Classification Date
    October 13, 2016
    Termination Date
    August 25, 2017
    Address
    14241 N Fenton Rd, N/A, Fenton, MI, 48430-1541, United States

    Description

    Zero-Gravity Radiation Protection System Radiology Personnel protective shield.

    Reason

    Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body shield will fall immediately. A fall of this nature places the user, associated staff and the patient at risk for a potential injury.

    Code Info

    All serial numbers for all models listed below manufactured/distributed between June 28, 2010  August 25, 2016. Part No. : Description ZGM-6-.5H : Zero-Gravity floor unit ZGM-6-5ROUNDH : Zero-Gravity floor unit ZGM-6Demo : Zero-Gravity demo floor unit ZGCM-48 : Zero-Gravity ceiling mounted monorail with 48 boom arm ZGCM-48-SPECIAL : Zero-Gravity ceiling mounted monorail with 48 boom arm with monorail extension ZG48 : Zero-Gravity 48 boom arm assembly and body shield for monorail ZGCM-66 : Zero-Gravity ceiling mounted monorail with 66 boom arm ZGCM-HSA : Zero-Gravity ceiling mounted monorail with hinged swing arm ZGCH : Zero-Gravity ceiling mounted monorail Contour track with 48 boom arm ZGCH48 : Zero-Gravity 48 boom arm assembly and body shield for Contour track ZGHSA : Zero-Gravity single point, ceiling mount with hinged swing arm ZGCSP : Zero-Gravity single point, ceiling mount with hinged swing arm 29858 : Zero-Gravity floor unit

    Distribution

    Nationwide. Canada. AUSTRALIA AUSTRIA BELGIUM BRUNEI CHINA FRANCE GERMANY INDA INDONESIA ISRAEL ITALY KSA MALAYSIA NETHERLANDS POLAND QATAR QUEBEC SAUDI ARABIA SINGAPORE SOUTH AFRICA TAIWAN (R.O.C.)

    Quantity

    447