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Terminated

Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA

FDA Recall Z-1003-2011 · Posted 2011-02-01

Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2010-04-19
Date Terminated2011-12-23
Product Quantity13

Reason for Recall

The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.

Firm Action

Varian issued via customer technical bulletin on April 19, 2010, to Varian Sales, Marketing and Service organization. Notification. The bulletin identified the product, the problem, and the action to be taken by the customer. Customers were asked to fill out the attached form and send it to their local Varial Medical Systems Field Service Office. For questions regarding this recall call 650-483-3153.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution - Japan only

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033339ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHYVarian Medical Systems, Inc. · 2003-12-30K904364VARIAN 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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