Events

Recall of Sirona Dac Universal Combination Steriliser

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Sirona Dental Systems 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-00771-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00771-1
  • 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
    Dac universal mkiii units may have been repaired using spare parts intended for mkii units. there is the possibility of 12mm screws being used as a replacement for the original 16mm screws in the lid holder assembly. in the case, where the incorrect screws are fitted the lid could possibly become unmounted from the unit during its operation. there is a risk that people standing nearby could be harmed if hit by a released lid.
  • Action
    Sirona is advising users to discontinue use of the affected machines until a service technician has inspected and corrected the machine, where required. Users are reminded to continue to manually clean and lubricate the instruments using T1 spray. This action has been closed out on 15 June 2017.

Device

Sirona Dac Universal Combination Steriliser
  • Model / Serial
    Sirona Dac Universal Combination SteriliserSerial Number Range: 104000-199999, 202000-999999, B14000-B99999, B104000-B199999, B202000-B999999ARTG Number: 197032
  • Manufacturer
    Sirona Dental Systems Pty Ltd

Manufacturer

Sirona Dental Systems Pty Ltd