Events

Recall of Device Recall Paper Chart Recorder

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gsi Group Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72936
  • Event Risk Class
    Class 2
  • Event Number
    Z-0866-2016
  • Event Initiated Date
    2015-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142532
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Recorder, paper chart - Product Code DSF
  • 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 customerservice@insidesales-solutions.com. 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.

Device

Device Recall Paper Chart Recorder
  • Model / Serial
    Serial Number range: 1801405 through 1918761
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
  • Product 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.
  • Manufacturer
    Gsi Group Inc

Manufacturer

Gsi Group Inc
  • Manufacturer Address
    Gsi Group Inc, 125 Middlesex Tpke, Bedford MA 01730-1409
  • Source
    USFDA