Company: ADAC Laboratories, Madison
Date of Enforcement Report: 5/19/04
Class: II
PRODUCT
a) Pinnacle3 Radiation Therapy Planning System, Model
Number 9200-9052A-ENG. Recall # Z-0911-04;
b) Pinnacle3 Radiation Therapy Planning System, Model
Number 9200-0613C-ENG. Recall # Z-0912-04;
c) Pinnacle3 Radiation Therapy Planning System, Part
Number 9104-2011A Rev. A. Recall # Z-0913-04;
d) Pinnacle3 Radiation Therapy Planning System, Part
Number 9104-0121C Rev. A. Recall # Z-0914-04;
e) Philips ADAC Pinnacle3 Radiation Therapy Planning
Software Packaage (Kit), Model Number 9200-0613B-ENG.
Recall # Z-0915-04;
f) Philips Pinnacle3 Radiation Therapy Planning Software
CD, Part Number 9104-0121B, Rev. A. Recall # Z-0916-04.
REASON
A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe.
CODE
a) Version 7.0e;
b) Version 6.6c;
c) Version 7.0e, Rev. A;
d) Version 6.6c, Rev. A;
e) Version 6.4a, Rev. A;
f) Version 6.4a, Rev. A;
RECALLING FIRM/MANUFACTURER
ADAC Laboratories, Madison, WI, by telephone and letters dated March 3, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
165 units.
DISTRIBUTION
Nationwide, Australia, Canada, China, and Korea.
