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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00771-1
Product Name/Description	Sirona Dac Universal Combination Steriliser Serial Number Range: 104000-199999, 202000-999999, B14000-B99999, B104000-B199999, B202000-B999999 ARTG Number: 197032
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	20/06/2016
Responsible Entity	Sirona Dental Systems Pty Ltd
Reason/Issue	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.
Recall Action	Recall for Product Correction
Recall Action Instructions	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.
Contact Information	02 9496 5100 - Sirona