Recall Z-0745-2016— Philips Medical Systems

Name: FDA recall Z-0745-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-08

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, initiated 2016-01-08, terminated 2016-10-05. It names one FDA 510(k) clearance: K130992. Product: DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621. Reason: 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..

Recalling firm: Philips Medical Systems
Classification: Class II
Status: Terminated
Initiated: 2016-01-08
Terminated: 2016-10-05
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K130992 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEMPhilips Medical Systems (Cleveland), Inc.·cleared 2013-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.