Recall Z-0594-2012 ยท IYE Accelerator, Linear, Medical
Philips Medical Systems (Cleveland), Inc.
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
| Date | Jan 11, 2012 (initiated Nov 18, 2011) |
| Status | Terminated |
| Reason | Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry. |
| Root cause | Software design |
| Action | 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 Americ |
| Quantity | 715 (463 US) |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Adac Laboratories, Jun 25, 2004 |