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).
This recall has been terminated (originally issued January 10, 2011).
- Recall Initiated
- January 26, 2009
- Posted
- January 10, 2011
- Terminated
- February 24, 2012
- Recall Number
- Z-0888-2011
- Quantity
- 3 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact.
Distribution
Product was distributed to 3 consignees in Florida and Wisconsin.
Lot / Code Info
Codes HZ5071, HZ59014 and HZ59017.
Root Cause
Device Design
Action Taken
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.
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