Events

Recall of PRN 50-M+ Digital Writer

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty Ltd.

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
    RC-2016-RN-00149-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00149-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has recently become aware of a potential safety issue associated with the flammability and fluid ingress rating of the outer enclosure material. there is an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the prn 50-m+ digital writer to meet its intended flammability and fluid ingress rating.
  • Action
    GE Healthcare is replacing all affected printers with unaffected units. This action has been closed-out on 22/02/2017.

Device

PRN 50-M+ Digital Writer
  • Model / Serial
    PRN 50-M+ Digital Writer Part Number: 600-23310-01 Units manufactured from May 28, 2013 through to April 7, 2015Serial Numbers: 1801405 through 1918761ARTG Number: 117497
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd