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U.S. Department of Health and Human Services

Class 2 Device Recall Pinnacle3 Software

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  Class 2 Device Recall Pinnacle3 Software see related information
Date Initiated by Firm July 31, 2014
Date Posted July 22, 2015
Recall Status1 Terminated 3 on May 08, 2019
Recall Number Z-2200-2015
Recall Event ID 71689
510(K)Number K041577  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
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.
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
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Customer Care Solutions Center
800-722-9377
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = ADAC LABORATORIES
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