Events

Recall of Aptio Automation Modules. An in vitro diagnostic medical device (IVD).

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-2016-RN-01310-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01310-1
  • 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
    An issue has been identified with the aptio automation modules. there is a possibility that the plug used to connect the automation system power source may overheat and fail. the plug used to connect to a standard power outlet is not affected.
  • Action
    Siemens is advising users to review customer letter with Medical Director, ensure all users are aware of the issue, return completed Response Form, retain letter with laboratory records and forward letter to those who may have received product. Siemens Customer Service Engineers shall be visiting customer sites to replace the power cords.

Device

Aptio Automation Modules. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Aptio Automation Modules. An in vitro diagnostic medical device (IVD).Module: Refrigerated Storage ModuleMaterial Number:10703049, 10715227, 10703036, 10713762 and 10713767Module: Centrifuge ModuleMaterial Number: 10703032, 10713761 and 10713764Module: i2000SR Interface ModuleMaterial Number: 10989303 and 10989304ARTG Number: 174699
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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