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Terminated

Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and distributed by Varian Oncology Systems, Palo Alto, CA The product is indicated for use in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy.

FDA Recall Z-0892-2011 · Posted 2011-01-11

Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Date Initiated2010-01-19
Date Terminated2012-02-24

Reason for Recall

There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly.

Firm Action

Varian sent an URGENT MEDICAL DEVICE CORRECTION letter via certified mail receipt on January 19, 2010, to all direct consignees. The letter identified the product, the problem, and the action the consignee should take. Consignees were instructed to have maintenance personnel perform the recommended measurements as described in the Varian Customer Technical Bulletin. Ensure that all measurements made as part of the procedure are recorded in the 'wear table' that is part of the procedure. Previous wear measurements should be compared to new measurements and any large increase in wear should be investigated immediately. Pay special attention to the "Recommendations based on wear measurements" table. Ensure that new wear measurements comply with the operating parameters described in the table. For any questions consignees are to contact Varian Medical Systems Customer Support Services at one of the locations described in the CTB. For questions regarding this recall call (650) 424-5731.

Root Cause

Other

Distribution Pattern

Worldwide Distribution including USA, Australia, New Zealand, Europe, Southeast Asia, China, Japan, Latin America, and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964138VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWAREVarian Medical Systems, Inc. · 1997-01-10K853349VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT STVarian Assoc., Inc. · 1985-10-28

Official Source

View FDA Recall →

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

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