Events

Recall of V5Ms transesophageal transducer (used for ultrasound imaging)

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-2014-RN-00943-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00943-1
  • 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
    Seiemens has received recent overseas reports about the deterioration of material covering the articulating section of the v5ms transesophogeal transducer. although to date, no patient injury has been reported, a compromise or fault in this material combined with a failure to use a probe cover as directed in the user manual may cause oesophageal cuts, bleeding, and perforation to the patient, and severe trauma, electrical burns, and serious electrical hazards to the patient and the user. however, a leakage current test can indicate cracks, cuts, tears, perforations, and protrusions in the articulation material.
  • Action
    To avoid the potential risk associated with this issue, customers are asked to undertake the following steps: - Perform the leakage current test for a transesophageal transducer prior to each use. - Use only Siemens approved cleaning and disinfecting solutions. - Use market-cleared transducer sheaths specifically designed for TEE applications. - When users store the transesophageal transducer, take extreme care that the distal tip is straight. Never move the distal tip by hand. Always use the flex controls. Customers are advised that if they notice any damage or wear on the transducer, or if the transducer fails to pass the leakage current test, immediately discontinue use of the transducer and contact their local Customer Service Engineer. This action has been closed-out on 06/06/2016.

Device

V5Ms transesophageal transducer (used for ultrasound imaging)
  • Model / Serial
    V5Ms transesophageal transducer (used for ultrasound imaging)Catalogue numbers: 08263703 and 8264577Serial number range: 32800000 to 42300000 (manufactured 2013-2014)ARTG number: 186302
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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