Focal Sim radiation therapy treatment planning system
This recall has been terminated (originally issued March 4, 2015).
- Company
- Elekta, Inc.
- Recall Initiated
- December 19, 2014
- Posted
- March 4, 2015
- Terminated
- August 7, 2017
- Recall Number
- Z-1244-2015
- Quantity
- 907
- Firm Location
- Atlanta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect CT to ED when using the Monaco Image Statistics Tool.
Distribution
Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulgaria, Bahrain, Brazil, Belarus, Canada, Chile, China, Colombia, Cuba, Cyprus, Czech Republic, Germany, Algeria, Egypt, Spain, France, Great Britain, Greece, Croatia, Indonesia, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Sri Lanka, Lithuania, Libya, Morocco, Macedonia, Mexico, Malaysia, New Zealand, Philippines, Portugal, Romania, Serbia, Russia, Singapore, Slovenia, Suriname, Thailand, Turkey, Ukraine, Venezuela, South Africa, Kosovo.
Lot / Code Info
Focal Release 4.80
Root Cause
Software design
Action Taken
An Important User Notice (IUN 382-03-FCL-001) was issued to customers on 12/19/2014. The notice included a workaround to be used until a new software release. The notice also included an acknowledgement form to be returned.