Events

Recall of Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Designs for Vision Aust 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-01424-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01424-1
  • 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, oculus optikgeräte, has identified recently that when a specific workflow sequence for performing the power calculation is utilised, the coloured display of the quality specification (qs) value changes from yellow to white, while the output values remained the same. the result is that the interpretation of the data, by solely considering the qs value, changes from “check the measurement results; repeating the measurement by having any doubts” (yellow flagged) to “the measurement is ok” (white flagged). although the device has a secondary warning (plausibility check) whereby the software flags any axial length difference greater than 0.3mm, indicating with a warning and displaying the suspicious difference of the axial length, the company has determined that in rare cases, this workflow sequence could result, in displaying an erroneous output. there have been no injuries as a result of this issue.
  • Action
    Paragon Care is providing users with a software upgrade as a permanent correction.

Device

Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13
  • Model / Serial
    Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13Serial Numbers: 0031 7130, 2721 6111, 3821 7110ARTG Number: 175820 (Designs for Vision Aust Pty Ltd - Corneal topography system)
  • Manufacturer
    Designs for Vision Aust Pty Ltd

Manufacturer

Designs for Vision Aust Pty Ltd