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Terminated

Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX

FDA Recall Z-1249-2011 · Posted 2011-02-15

Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2010-06-23
Date Terminated2011-05-03
Product Quantity5741 units

Reason for Recall

Position errors may result in misdelivery of radiation.

Firm Action

Varian sent Urgent Medical Device Correction letters on June 23, 2010 by Federal Express to all customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** Field Safety notification including customer distribution lists, was e-mailed to Varian international Customer Support Managers. Managers will translate to local language if necessary, notify sites by appropriate methods.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070094TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEMVarian Medical Systems, Inc. · 2007-02-09K913119VARIAN C-SERIES CLINACS (CLINAC 2300C/D)Varian Assoc., Inc. · 1991-11-07K904364VARIAN 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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