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Terminated

Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.

FDA Recall Z-1312-2014 · Posted 2014-03-31

Recalling FirmPhilips Medical Systems (Cleveland), Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2014-02-11
Date Terminated2014-11-21
Product Quantity1016

Reason for Recall

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.

Firm Action

Philips Healthcare sent an Urgent Field Safety Notice dated February 10, 2014, to all affected consignees. The letter included the Problem Description, Hazard Involved, How to Identify Affected Products, Action to be taken by Customer /User, Actions Planned by Philips and Further Information and Support. Consignees were instructed to review the following information with all members of their staff who need to be aware of the contents of this communication including clinics within their institution that are remotely connected to their Pinnacle Server. Customers were questions were instructed to contact their Philips representative. For customers in North America please contact Customer Care Solutions Center at 1-800-722-9377. For all other countries their local Philips Healthcare Office should be contacted. For questions regarding this recall call 1-800-722-9377.

Root Cause

Software design

Distribution Pattern

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. .

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041577PINNACLE3 RADIATION THERAPY PLANNING SYSTEMAdac Laboratories · 2004-06-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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