Recall Z-1643-2015— Philips Medical Systems, Inc.

Name: FDA recall Z-1643-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-23

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2015-04-23, terminated 2016-10-05. It names one FDA 510(k) clearance: K041577. Product: Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of treatment to a patient.. Reason: A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. Specifically, the dose engine is being passed the wrong snout position. The snout position is used to determine the penumbra of the beam which includes the calculation of the source si.

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-23
Terminated: 2016-10-05
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K041577 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEMAdac Laboratories·cleared 2004-06-25

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

Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of treatment to a patient.

Reason for recall

A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. Specifically, the dose engine is being passed the wrong snout position. The snout position is used to determine the penumbra of the beam which includes the calculation of the source si

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