Pinnacle Therapy Planning System - Kit (2014-07-30)

Starting date:

July 30, 2014

Posting date:

August 22, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-41121

• Reason
• Affected products

Recalled Products

Pinnacle Therapy Planning System – Kit 

Reason

Philips has become aware that the dose may be inconsistent with the density of a density-over ridden region of interest (ROI). The issue occurs under certain specific conditions where the user modifies a contour in a density-over ridden ROI with density set to a specific value in a computed plan, dose is subsequently invalidated and the user may recomputed the dose. In this case, the density can be replaced by the CT number from the CT to density table when recomputed resulting in an incorrect dose and the monitor units (MU) may then be much higher than originally planned. The user may continue, and save the plan with incorrect dose. When the plan is reopened, the density is reported as the correct value but the dose remains incorrect based on the prior incorrect value for density.

Affected products