Events

Recall of SOMATOM CT System SOMATOM Definition Flash running software version syngo CT2012B SOMATOM Definition Edge running software version syngo CT2012B SOMATOM Definition AS running software version syngo CT2012B SOMATOM Definition running software version syngo CT2012B SOMATOM Definition AS running software version syngo CT2013

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-01317-1
Event Risk Class
Class I
Event Initiated Date
2013-12-11
Event Country
Australia
Event Source
DHTGA
Event Source URL
https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01317-1
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 a software malfunction that may lead to a system display freeze during interventional procedures. if the function, "auto save last displayed images as key images" is activated during an interventional procedure, the software configuration allows conflicting access to the ct system image database. in such situations, a system display freeze might occur. normal interaction with the system is then no longer possible. no error message is issued and only a system restart resolves the problem. in case of a sudden system display freeze the interventionalist will potentially not immediately recognise the malfunction and continue the interventional procedure. there is a possibility of injury to a patient.
Action
Siemens advising users to deactivate the "Auto save last displayed images as key images" function to prevent the issue from occurring. Images can continue to be saved manually. Siemens is providing a software update to permanently correct the issue in February 2014. This action has been closed-out on 29/01/2016.

Device

SOMATOM CT System SOMATOM Definition Flash running software version syngo CT2012B SOMATOM Definit...

Model / Serial
SOMATOM CT System SOMATOM Definition Flash running software version syngo CT2012BSOMATOM Definition Edge running software version syngo CT2012BSOMATOM Definition AS running software version syngo CT2012BSOMATOM Definition running software version syngo CT2012BSOMATOM Definition AS running software version syngo CT2013BARTG numbers: 164065 (SOMATOM system),160853 (syngo software)
Manufacturer
Siemens Ltd

Manufacturer

Siemens Ltd

Manufacturer Parent Company (2017)
Siemens AG
Source
DHTGA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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