Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use with a charged particle accelerator (such as the Clinac 600C).
FDA Recall Z-0888-2011 · Posted 2011-01-10
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Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2009-01-26
Date Terminated2012-02-24
Product Quantity3 units
Reason for Recall
Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact.
Firm Action
Varian sent an urgent device correction notification letter 01/26/2009 to all affected users, with a description of the problem and user corrective action steps via certified mail. The letter will also be distributed to Varian Sales, Marketing and Service organizations.
Root Cause
Device Design
Distribution Pattern
Product was distributed to 3 consignees in Florida and Wisconsin.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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