Events

Recall of ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware and Auxiliary (AUX IN/OUT) cable

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-2018-RN-00241-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00241-1
  • 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
    Siemens has identified that in some cases the ecg signal may flatline due to electromagnetic interference when used in conjunction with electrosurgical equipment. the electrosurgical equipment creates electromagnetic interference (emi) which is then transmitted to the physio module and the sc2000 system through the aux in/out cable. this interference causes the system to lose communication with the physio module. to date, there have been no reported injuries as a result of this issue.
  • Action
    Siemens is advising: If the ECG trace disappears or flatlines, perform the following steps to disable the ECG trace and exit the physio module functionality: 1. Press F13 (Physio) on the keyboard. 2. Press the scroll wheel to select the appropriate ECG or AUX trace option and then press the Off soft key. 3. To exit the Physio menu, press F13 (Physio) again. After these steps are performed, the ultrasound system will use time-based captures instead of beat captures. Also note that the system may be rebooted to reset the ECG trace. However, if the electrosurgery equipment is used again the symptom will reoccur. This issue will be resolved by a hardware update to affected systems. Siemens Customer Service will contact users to schedule this replacement if the system configuration is affected by the scope of this issue.

Device

ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware...
  • Model / Serial
    ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware and Auxiliary (AUX IN/OUT) cableCatalogue number: 10433816ARTG Number: 139591Siemens Healthcare - Ultrasound system, imaging, cardiovascular
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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