The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Sonopet Console, manufactured by Stryker. The affected catalogue number is 5450852000 and the affected serial numbers are 1134000114, 1134000124, 1134000134, 1134000144, 1134000184, 1134000204 & 1209400174.
According to the TGA, the manufacturer has received reports that the Irrigation Pump may not function and audible alarm may not sound. In case where the irrigation pump fails, saline would not be provided to the tip. The manufacturer will be replacing affected units with a loan unit until the unit is repaired.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00578-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Jun 2013