Z-2200-2015Class II

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

Name: Z-2200-2015 Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161...
Creator: Philips Electronics North America Corporation
Published: 2014-07-31
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-07-31 / Terminated / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED... on 2014-07-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2200-2015
Classification: Class II
Status: Terminated
Initiated: 2014-07-31
Posted: 2015-07-22
Terminated: 2019-05-08
Recalling firm: Philips North America LLC
Product: 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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were sent on 7/31/2014 a Philips "Urgent Field Safety Notice" dated 2014-July 20. The letter described the problem, product involved in the recall and the action that should be taken by the customers. For questions contact Customer Care Solutions Center at 1-800-722-9377. UPDATE: A second Philips letter dated 2 July 2015 was sent in August 6, 2015. This letter updated the recall to incorporate the additional products being recalled.
Quantity in commerce: 1642
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2200-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2200-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22

Product code LNH

K041577Class IIPinnacle3 Radiation Therapy Planning SystemAdac Laboratories / cleared 2004-06-25

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)