Reported Jul 29, 2015 · Terminated

Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931,…

Philips Electronics North America Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

    • 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
Lot codes and dates
    • 453560446041
    • 459800091001
    • 459800220161
    • 459800232931
    • 459800235871
    • 459800338451
  • UPDATED453560446051 [A] 459800096361 [Al 453560446061 IA] 459800096541 [A] 453560446091 [A] 459800096741 [A] 453560446101 [A] 459800096921 [A] 453560446111 [A] 459800097111 [A] 453560446131 [A] 459800097291 [A] 453560446141 [A] 459800097471 [A] 453560446161 [A] 459800097651 [B] 453560446181 [A] 459800097831 [B] 453560446201 [A] 459800098171 [B] 459800089221 [A] 459800098351 [A] 459800091451 [A] 459800109261 [A] 459800138101 [BJ 459800189431 [A) 459800220131 [B] 459800239171 [A] 459800233271 [8] 459800233281 [A] 459800233291 [B] 459800233301 [A] 459800233311 [8] 459800233321 [B] 459800233331 [B] 459800233341 [A] 459800233351 [A] 459800233361 [A] 459800234101 [A] 459800234111 [A] 459800234121 [A] 459800318391 [Al 459800405751 [A] 459800417961 [A] 459800249651 [8] 459800249721 [A] 459800249851 [A] 459800249931 [A] 459800250001 [Al 459800250081 [A] 459800250151 [A] 459800250221 [A] 459800250291 [A] 459800250361 [A] 459800250431 [A] 459800250501 [A] 459800250571 [A] 459800338961 [B] 459800340181 [A] 459800340201 [A] 459800341171 [A] 459800341191 [A] 459800341481 [A] 459800341501 [A] 459800345001 [A] 459800345021 [A] 459800345041 [A] 459800345061 [A] 459800345081 [A] 459800345101 [A] 459800454251 [A] 459800455341 [A] 459800493591 [A] 459800494011 [A] 459800554831 [A] 459800554881 [A] 453560435761 453560434881 453560454791 453560461331 453560461341
Amount recalled
1642

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 8, 2019 · Data as of Sep 19, 6:39 PM UTC

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