—#105776

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041577
Affected lot / code info: 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

Why it was recalled

Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland), Inc.
Address: 5520 Nobel Dr, Ste 125, Fitchburg, Wisconsin 53711-4948

Distribution

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.

Timeline

Recall initiated: 2011-11-18
Posted by FDA: 2012-01-11
Terminated: 2014-02-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105776. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.