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Class 2 Device Recall Pinnacle3 Radiation Therapy Planning System |
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Date Initiated by Firm |
November 18, 2011 |
Date Posted |
January 11, 2012 |
Recall Status1 |
Terminated 3 on February 28, 2014 |
Recall Number |
Z-0594-2012 |
Recall Event ID |
60549 |
510(K)Number |
K041577
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Product Classification |
System, nuclear magnetic resonance imaging - Product Code IYE
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Product |
Pinnacle3 Radiation Therapy Planning System, software version 9.0.
Model # Description 453560446041 Pinnacle3 version 9.0 English 453560446051 Pinnacle3 version 9.0 Simplified Chinese 453560446061 Pinnacle3 version 9.0 Traditional Chinese 453560446091 Pinnacle3 version 9.0 Dutch 453560446101 Pinnacle3 version 9.0 French 453560446111 Pinnacle3 version 9.0 German 453560446141 Pinnacle3 version 9.0 Italian 453560446161 Pinnacle3 version 9.0 Japanese 453560446181 Pinnacle3 version 9.0 Spanish 453560446201 Pinnacle3 version 9.0 Turkish
Intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes.
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Code Information |
System Code # 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446111 453560446111 453560446041 453560446101 453560446041 453560446101 453560446041 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446041 453560446041 453560446041 453560446101 453560446101 453560446041 453560446101 453560446041 453560446111 453560446041 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446051 453560446041 453560446141 453560446141 453560446041 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446041 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446181 453560446181 453560446101 453560446041 453560446061 453560446041 453560446061 453560446061 453560446041 453560446041 453560446041 453560446201 453560446041 453560446041 453560446041 453560446041 453560446041 |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland), Inc. 5520 Nobel Dr Ste 125 Fitchburg WI 53711-4948
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For Additional Information Contact |
608-298-6901
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Manufacturer Reason for Recall |
Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry.
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FDA Determined Cause 2 |
Software design |
Action |
Consignees were sent on 11/18/11 a Philips "Urgent Medical Device Correction" letter dated 2011 Nov 16. The letter identified the affected product and described the Problem, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer/User, Actions Planned by Philips and Further information and Support. If customers observed the issue, they were to manually make the suggested change. In addition, customers were to place the letter in the Instructions for Use until otherwise notified. The firm will deliver 9.2 software release free of charge. Customers in North America are to contact Customer Care Solutions Center at 1-800-722-9377, if they have questions or need support concerning the recall. |
Quantity in Commerce |
715 (463 US) |
Distribution |
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and countries of AUSTRALIA, AUSTRIA, BELGIUM, CHINA, DENMARK, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, OMAN, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM, and CANADA. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = ADAC LABORATORIES
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