BEUDAMED
    FDA Enforcement Class II Terminated

    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.

    Recall: Z-0866-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0866-2016
    Event ID
    72936
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gsi Group Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    December 2, 2015
    Classification Date
    February 24, 2016
    Termination Date
    June 6, 2018
    Address
    125 Middlesex Tpke, N/A, Bedford, MA, 01730-1409, United States

    Description

    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.

    Reason

    The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer

    Code Info

    Serial Number range: 1801405 through 1918761

    Distribution

    Worldwide Distribution - US Nationwide including Puerto Rico; Internationally: Australia, Bahamas, Canada, Germany, Finland, France, Great Britain, Hong Kong, India, Ireland, Italy, Japan, South Korea, Mauritus, Mexico, Peru, Saudi Arabia, Singapore, Taiwan, United Arab Emirates & United Kingdom

    Quantity

    2257 units