FDA-Device2014-04-09Class II
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
Philips Medical Systems (Cleveland), Inc.
Hazard
Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013.
Sold states
Worldwide Distribution - USA including US: 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 Internationally to AUSTRALIA, AUSTRIA. BELGIUM, CANDA, CHINA, DENMARK, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MALAYSIA, MEXICO, MONTENEGRO, NETHERLANDS, NEW ZEALAND, OMAN, RUSSIA, SOUTH ARICA, SOUTH KOREA. SPAIN,. SWITZERLAND, TAIWAN, THAILAND, TURKEY, EMIRATES, UNITED KINGDOM. .
Affected count
1016
Manufactured in
5520 Nobel Dr Ste 125, N/A, Fitchburg, WI, United States
Products
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1312-2014Don't want to check this manually?
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