Events

Recall of e.cam and Symbia E systems (Nuclear medicine gamma camera system)

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-01052-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-08-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01052-1
  • 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 received reports of patients’ hair being caught in the e.Cam and symbia e patient bed up/down drive. siemens is reminding users of the patient positioning instructions for the e.Cam or symbia e systems. additionally, an enhancement kit that reduces the gap in the patient bed up/down drive has been designed and will be installed by siemens.
  • Action
    Siemens is reminding users of the positioning instructions for the e.cam and Symbia E systems that require operators to properly position the patient and observe the patient at all times. Siemens will be arranging for an enhancement kit to be installed by a Siemens service representative. This action has been closed-out on 23/06/2017.

Device

e.cam and Symbia E systems (Nuclear medicine gamma camera system)
  • Model / Serial
    e.cam and Symbia E systems (Nuclear medicine gamma camera system)Catalogue Numbers: 4380213, 4380221, 5242826, 5977066, 5977074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7324119, 7324135, 7324143, 7324150, 7760809, 7760932, 7761161, 7823920, 7823938, 7823946, 7823953, 7823961, 7823979, 10151531, 10151532, 10275879, 10413009, 10520745ARTG Numbers: 186317, 186317
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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