Z-1643-2015Class II

Pinnacle3 Software Version 10.0, Model 459800200841

Name: Z-1643-2015 Pinnacle3 Software Version 10.0, Model 459800200841
Creator: Philips Medical Systems, Inc.
Published: 2015-04-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-04-23 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data... on 2015-04-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1643-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-23
Posted: 2015-05-21
Terminated: 2016-10-05
Recalling firm: Philips North America LLC
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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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
Root cause tag: software
FDA root cause: Software design
Action: 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).
Quantity in commerce: 4
Distribution: US Nationwide Distribution in the states of MO, FL, OH
Product codes and lots: "System Code S/N" 1439NML05A, 1117FMM025, DC090775040, 1117FMM03J.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1643-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1643-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-21

Product code MUJ

K041577Class IIPinnacle3 Radiation Therapy Planning SystemAdac Laboratories / cleared 2004-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)