—#142775

Product

DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K130992
Affected lot / code info: Software Version 10.0.0 and 14.0.0

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 ).

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2016-01-08
Posted by FDA: 2016-02-02
Terminated: 2016-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142775. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.