Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and distributed by

FDA device recall Z-0892-2011 · posted 2011-01-11 · Terminated

Recall details

Recalling firm

Varian Medical Systems Oncology Systems

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.

Action taken

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

Status

Terminated

Distribution

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

Date initiated

2010-01-19

Date posted

2011-01-11

Date terminated

2012-02-24

Location

Palo Alto, CA

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