Events

Recall of Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Swirl Technologies Pty Ltd T/A Parker Healthcare.

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-00845-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00845-1
  • 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 advised that some devices have excessive background noise. this has been determined to be caused by an issue with the transistor circuit.
  • Action
    Complete the supplied Verification Facsimile/Email Reply Form and then return it as directed to Parker. If any of the investigated products have been transferred to another facility, please immediately let that facility know of this Recall for Product Correction, and record it on the Verification Facsimile/Email Reply Form. If the excessive noise is suspected to be present, or you have any Technical inquiry, please contact Parker Healthcare Service Department as directed. These units will be returned to the Manufacturer in the USA for product correction.

Device

Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular
  • Model / Serial
    Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular ARTG Number: 128657 (Swirl Technologies Pty Ltd T/A Parker Healthcare - Ultrasound system, non-imaging, Doppler blood-flow measurement)Serial Number(s):Model: 3 MHz ObstetricSerial Number: CAQ0472
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA