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Terminated

Focal Sim radiation therapy treatment planning system

FDA Recall Z-1244-2015 · Posted 2015-03-04

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2014-12-19
Date Terminated2017-08-07
Product Quantity907

Reason for Recall

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

Firm Action

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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013112FOCAL SIMComputerized Medical Systems, Inc. · 2001-12-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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