Recalls / —

—#133680

Product

Focal Sim radiation therapy treatment planning system

FDA product code

MUJ — System, Planning, Radiation Therapy Treatment

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K013112

Affected lot / code info

Focal Release 4.80

Why it was recalled

Incorrect CT to ED when using the Monaco Image Statistics Tool.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

Elekta, Inc.

Address

400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2014-12-19

Posted by FDA

2015-03-04

Terminated

2017-08-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #133680. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.