Company: Elekta, Inc.
Date of Enforcement Report 3/30/2011
Class ll:
PRODUCT
Elekta Synergy XVI R4.5 Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Recall # Z-1723-2011
REASON
If another patient is selected on the imaging system (XVI) release 4.5) during the transmission of end of treatment data from Desktop Pro R7.01 to R&V system, the XVI information is prioritized and the end of treatment data is never received by the R&V system.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated January 26, 2011.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, United Kingdom.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Nationwide
