Philips Medical Systems: Medical Device Recall in 2016 - (Recall #: Z-0745-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621

Product Classification:

Class II

Date Initiated: January 8, 2016

Date Posted: February 10, 2016

Recall Number: Z-0745-2016

Event ID: 73023

Reason for Recall:

In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.

Status: Terminated

Product Quantity: 3

Code Information:

Software Version 10.0.0 and 14.0.0

Distribution Pattern:

US: Nationwide Distribution in the states of FL, OH, and MO.

Voluntary or Mandated:

Voluntary: Firm initiated