Events

Recall of Biograph mMR with software version syngo E11P

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-00113-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00113-1
  • 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 been notified by the manufacturer that a mismatch has been identified between orientation labels and displayed anatomy (e.G. in the 3d task card) within the software version syngo e11p. this will lead to wrong attenuation correction of the pet data.The issue occurs when changing the image numbering in transversal mrac protocol (e.G. mrac_caipi_hires protocol) from the default setting "feet>>head" to a customised setting "head>>feet". the original images are labelled correctly, but the composed images are flipped by 180 degrees and shifted.There have been no injuries reported as a result of this issue.
  • Action
    Siemens is advising that this issue will be corrected in the next service pack syngoE11P-SP03. In the interim, do not change the numbering of images in transversal MRAC protocols (within an MRPET workflow). Follow the user manual. Don't rely only on composed images; always additionally refer to the original images for diagnostic purposes.

Device

Biograph mMR with software version syngo E11P
  • Model / Serial
    Biograph mMR with software version syngo E11PCatalogue Number:10433372ARTG Number: 274035
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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