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Terminated

Clinac with Version 7.x Software, manufactured by Varian Medical Systems, Palo Alto, CA. Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy.

FDA Recall Z-1729-2009 · Posted 2009-08-27

Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2009-05-29
Date Terminated2011-05-18
Product Quantity1,933 units

Reason for Recall

Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly.

Firm Action

Varian Medical Systems issued an "Urgent Medical Device Correction" dated May 29, 2009 distributed to all affected users, as well as Varian Sales, Marketing and Service organizations, informing them of the issue. Consignees were informed that a Varian Service representative will be in contact to schedule the proper correction. For further questions, contact your local Varian Customer Support District Manager.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K904364VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500CVarian Assoc., Inc. · 1991-02-27

Official Source

View FDA Recall →

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

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