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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71689

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 31, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Electronics North America Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2200-2015
Recall number
Z-2200-2015
Initiated
July 31, 2014
Classification
Class II
Status
Terminated
Quantity
1642

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451 UPDATED: 453560446051 [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

Distribution pattern

Worldwide Distribution-US: All states in the US including DC and PR. OUS: Australia, Austria, Bangladesh, Belgium, Brazil, China, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands,New Zealand, Oman, Philippines, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Viet Nam. UPDATED: Canada, Bulgaria, Egypt, Hungary, Jordan, Luxembourg, Poland, Reunion, Romania, Russia, Sauth Arabia, Turkey.

Field note

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