Recall Z-1312-2014 ยท MUJ System, Planning, Radiation Therapy Treatment
Philips Medical Systems (Cleveland), Inc.
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
| Date | Mar 31, 2014 (initiated Feb 11, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| 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 |
| Quantity | 1016 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Adac Laboratories, Jun 25, 2004 |