Z-0745-2016Class II

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

Name: Z-0745-2016 DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System...
Creator: Philips Medical Systems
Published: 2016-01-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-01-08 / Terminated / root cause: design

FDA source

Philips Medical Systems began a recall of DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621 on 2016-01-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0745-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-08
Posted: 2016-02-02
Terminated: 2016-10-05
Recalling firm: Philips North America LLC
Product: DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: design
FDA root cause: Device Design
Action: Philips sent an "Urgent Medical Device Correction" letter dated 16-DEC-2015 to affected customers. The letter described the Affected Products, 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: 3
Distribution: US: Nationwide Distribution in the states of FL, OH, and MO.
Product codes and lots: Software Version 10.0.0 and 14.0.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0745-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0745-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-02

Product code IYE

K130992Class IIPinnacle3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. / cleared 2013-06-14

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)