Events

Recall of ACUSON SC2000 System (Ultrasound cardiovascular imaging system) when used with V5M Transducer (which includes revision 4 of the MPI board)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens 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-2013-RN-00325-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00325-1
  • 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
    When using the v5m transducer, the display of the temperature on the acuson sc2000 system can be lower than the actual temperature of the v5m transducer. this occurs only if the system hardware contains revision 4 of the mpi board. if this condition occurs when scanning a febrile or hyperthermic patient using maximum system power settings (0 db), the actual lens surface temperature could exceed 43degc while the system temperature display continues to show a value under 43degc. there is a potential to cause oesophageal burns in patients with body temperatures greater than 40degc.Products supplied in australia include a different transducer (4z1c) which cannot be used for trans-oesophageal imaging. potential for heating with this model is mitigated by independent mechanical cooling which is not dependent on a feedback mechanism. siemens is correcting all models including revision 4 of the mpi board irrespective of the transducer version.
  • Action
    Siemens is providing temporary work around instructions and is implementing an upgrade of the system hardware that will correct the issue.

Device

ACUSON SC2000 System (Ultrasound cardiovascular imaging system) when used with V5M Transducer (wh...
  • Model / Serial
    ACUSON SC2000 System (Ultrasound cardiovascular imaging system) when used with V5M Transducer (which includes revision 4 of the MPI board)ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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