Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Pinnacle3 Software Version 9.0 Recalled by Philips Electronics North America Corporation Due to Philips, Pinnacle Radiation Treatment Planning System version 8.0h,...

Date: July 31, 2014
Company: Philips Electronics North America Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Electronics North America Corporation directly.

Affected Products

Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.

Quantity: 1642

Why Was This Recalled?

Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl.

Where Was This Sold?

This product was distributed to 1 state: DC

Affected (1 state)Not affected

About Philips Electronics North America Corporation

Philips Electronics North America Corporation has 160 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report