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Philips Medical Systems (Cleveland), Inc. recalls Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.

Recalled April 9, 2014 · FDA recall Z-1312-2014 · Philips Medical Systems (Cleveland)

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. · FDA Class II
Units
1016
Sold at
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. .

Description

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.

Product
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
Manufacturer(s)
Philips Medical Systems (Cleveland), Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Philips Medical Systems (Cleveland), Inc. recalls Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. | RecallWatchUSA