BEUDAMED
    FDA Recall 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 · Initiated December 2, 2015

    Recall

    Recall Number
    Z-0866-2016
    Event Number
    72936
    Firm
    Gsi Group Inc
    FEI Number
    3007083974
    Product Code
    DSF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 2, 2015
    Terminated
    June 6, 2018
    Address
    125 Middlesex Tpke, Bedford, MA, 01730-1409

    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

    Action

    On December 2, 2015 GSI Group Corp. distributed Medical Device Correction Notice letter and confirmation forms dated November 18, 2015 to their customers via FedEx. GSI Group Corp. warned customers about a potential safety issue associated with the flammability and fluid ingress rating of the outer enclosure material. Customers are advised to follow all intended usage, cleaning and maintenance instructions that are found in the PRN 50-M+ Digital Writer Technical Manual. It is recommended that customers complete and return the attached Medical Device Correction Confirmation form via email to [email protected]. GSI Group Corp. will provide a correction at no charge. Once the confirmation form is received, GSI Group Corp. will make arragements to send replacements. Customers with questions can call 781-266-5700.

    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