—#136154

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.

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041577
Affected lot / code info: "System Code S/N" 1439NML05A, 1117FMM025, DC090775040, 1117FMM03J.

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

Philips Healthcare sent a "Field Safety Notification PROST-T-300-01-06" letter dated 20 April 2015 to their customers. The letter described the Problem Description, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer / User, Actions Planned by Philips and Further Information and Support (Contact Philips Customer Care Solutions Center at 1-800-722-9377).

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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

Timeline

Recall initiated: 2015-04-23
Posted by FDA: 2015-05-21
Terminated: 2016-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.