Philips Medical Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1643-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 23, 2015

Date Posted: May 27, 2015

Recall Number: Z-1643-2015

Event ID: 71117

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

Status: Terminated

Product Quantity: 4

Code Information:

"System Code S/N" 1439NML05A, 1117FMM025, DC090775040, 1117FMM03J.

Distribution Pattern:

US Nationwide Distribution in the states of MO, FL, OH

Voluntary or Mandated:

Voluntary: Firm initiated