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.
FDA Recall Z-0594-2012 · Posted 2012-01-11
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Recalling FirmPhilips Medical Systems (Cleveland), Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-11-18
Date Terminated2014-02-28
Product Quantity715 (463 US)
Reason for Recall
Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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