Events

Recall of ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-2014-RN-00405-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00405-1
  • 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
    Philips healthcare received a report from the field about an adac vertex plus system. during clinical use in the relative 180 degree configuration of the detector heads, the radius drive belt in the superior positioned head slipped off the idler pulley, allowing the detector head to drift down slowly (approximately 1 cm per minute) towards the patient. this resulted in the operator having to perform an emergency removal of the patient from the system. there have been no reports of serious injury or death as a result of this situation.
  • Action
    Hospitals are requested to cease use of "Relative 180 degree SPECT" and "pinhole collimator" procedures until the implementation of the correction. Philips will replace the two radius drive belts and idler pulleys to correct the problem.

Device

ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus Systems

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA