Events

Recall of Integrity R1.2 and Integrity R3.2 systems with a Precise Treatment Table for ATM license option

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Elekta 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-01407-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01407-1
  • 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
    Elekta have identified that it is possible to get a positional error with the precise treatment table following automatic table movement. this can occur if there is an undetected failure of the positional sensors. this has been previously communicated through notification 200-01-204-011 (rc-2014-rn-00927-1).It is possible to deliver treatment with the patient in an incorrect position, if this fault were to occur and go undetected.
  • Action
    Recipients should distribute this notice to all users of the system and include a copy of the notice with the system manuals. The supplied Field Safety Notice serves to reiterate the importance of a procedure to check for the error already present in the IFU, previously communicated to customers (TGA Ref: RC-2014-RN-00927-1). Users should continue to follow the recommended daily QA checks detailed in the IFU, also present in the previous Field Safety Notice, until the software upgrade is released. Acknowledge the receipt of this notice by completing the Confirmation of receipt form you receive from Elekta's automated distribution system. Please return the form to Elekta even if you no longer have the affected units at your site. Elekta will release Integrity™ R4.0.0, which will identify positional errors over 5 mm if a sensor has failed. Upgrades in the field are expected to start in the first half of 2018. Elekta will contact users to plan and schedule this upgrade.

Device

Integrity R1.2 and Integrity R3.2 systems with a Precise Treatment Table for ATM license option
  • Model / Serial
    Integrity R1.2 and Integrity R3.2 systems with a Precise Treatment Table for ATM license optionARTG Number: 191025
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    DHTGA