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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00291-1
Product Name/Description Pinnacle3 Radiation Treatment Planning System, software version 9.0

ARTG Number: 118156
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 11/03/2014
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue When the user changes from one treatment machine to another, the jaw symmetry Yes or No option may be set incorrectly to symmetric. When exported via DICOM RT, Multileaf Collimator (MLC) and jaw positions agree with the Pinnacle3 plan. However, because the jaw symmetry flag is set to yes, the Record and Verify (R&V) system may force the jaws to be symmetric, thereby re-positioning the beam. The resulting beam on the R&V system does not match the beam in Pinnacle3 resulting in an incorrect dose to the target or other structure. If the situation is noticed prior to completion of the treatment, the incorrect beam could be corrected to give the correct total dose.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is providing an update to software version 9.2 to all customers who have software version 9.0 installed. Until the update is applied, customers are advised to manually cick the button to set it to No if they observe the jaw symmetry is set to Yes inappropriately.
Contact Information 1800 251 400 - Phillips Customer Care Centre