TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radiation treatment is indicated. Varian Medical Systems, Palo Alto, CA.
FDA Recall Z-1617-2012 · Posted 2012-05-16
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Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-04-09
Date Terminated2014-04-16
Product Quantity207 devices 12/7/12 - amended to 216 devices.
Reason for Recall
Varian received a report involving a Gantry collision and is sending a notification to remind users of the collision protection tools available with TrueBeam and TrueBeam STx, including actions the operator should be aware of.
Firm Action
An "Urgent Medical Device Correction / Field Safety Letter" was distributed to all affected users on April 9, 2012, with a description of the problem and user corrective action steps. The Letter was also distributed to the Varian Sales, Marketing, and Service organizations. Customers in the US and Canada may contact (888) 827-4265 for questions.
*** An additional letter was sent on 11/5/12 to additional consignees identified by Varian as being affected the the recall but not previously notified.
Root Cause
Labeling design
Distribution Pattern
Worldwide Distribution -- USA, and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Netherlands, New Zealand, Norway, Portugal, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and the United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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