Events

Recall of Acuson SC200 ultrasound systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare 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-2016-RN-00353-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00353-1
  • 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
    Due to an alignment issue with the bezel on the front panel, the plastic cover around the transducer ports prevents full contact of the connector on the transducer to the transducer port on the system. this issue causes the system to lock up.This may result in a delay in diagnosis while an alternative exam is performed.
  • Action
    Siemens is advising users that in the event a transesophageal transducer is inserted in a patient, the user should first disconnect and reconnect the transducer. If the system still locks up, the user should then follow the instructions on the screen and disconnect the transducer, remove the transducer from the patient, and contact a Siemens service representative. Siemens will be replacing the front panel of the system as a permanent fix.

Device

Acuson SC200 ultrasound systems
  • Model / Serial
    Acuson SC200 ultrasound systemsAffected Serial Numbers: 400300 and belowCatalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA