Events

Recall of Laser photocoagulator Easyret software version 1.03

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2017-RN-00507-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-04-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00507-1
  • 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 quantel medical has become aware of an issue with the micropulse mode of the easyret laser (qm-pabx0017, serial number 155) in software version 1.03. if the validation key of the intermediate window for treatment lens and spot size selection is pressed twice when selecting the micropulse mode, a software bug leading to the delivery of an erroneous level of energy corresponding to a 100% duty cycle when in treatment session will be created. this issue could cause photocoagulation of the retina in patients.
  • Action
    Device Technologies Australia (DTA) is advising users to discontinue use of the MicroPulse mode on the device until the software update in version 1.04 has been completed by a DTA representative. This action has been closed-out on 15/03/2018.

Device

Laser photocoagulator Easyret software version 1.03

Manufacturer

Device Technologies Australia Pty Ltd