Terminated

XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

FDA Recall Z-0130-2016 · Posted None

Recalling FirmElekta, Inc.

Recall StatusTerminated

Product CodeMUJ

Date Initiated2015-08-31

Date Terminated2021-09-15

Product Quantity1440 units

Reason for Recall

Incorrect Treatment Delivery Using Third Party Fixed Wedges.

Firm Action

Consignees were notified via URGENT FIELD SAFETY ALERT, on 08/31/2015.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution-Domestic: AK, AL, AZ, CA, CO, CT, DC, FL, IN, IL, KY, MA, MD, MI, MN, MO, NJ, NC, ND, NY, OH, OK, PA, PR, TN, TX, VA, WA and WI; International: Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, France, Gabon, Germany, Greece, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Macedonia, Malaysia, Mali, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, The United Kingdom, Ukraine, Venezuela and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102216XIO RTP SYSTEMComputerized Medical Systems, Inc. · 2010-10-01

Official Source

View FDA Recall →

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