Company:Elekta, Inc.
Date of Enforcement Report 12/15/11
Class ll:
PRODUCT
Elekta Synergy XVI R.4.5 and R4.6 Product Usage: To be used as part of radiation therapy treatment process. Recall # Z-0320-2012
REASON
The software did not operate as expected.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 14, 2011.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, UK. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
77 units
DISTRIBUTION
Nationwide and PR
