FDA Medical Device Recalls (openFDA)
Varian Medical Systems Oncology Systems: 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).
- Recall number
- Z-0888-2011
- Recalling firm
- Varian Medical Systems Oncology Systems
- Product
- 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).
- Status
- Terminated
- Initiated
- 2009-01-26
- Posted
- 2011-01-10
- Terminated
- 2012-02-24
- Reason
- Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact.
- Root cause
- Device Design
- 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.
- Quantity
- 3 units
- Distribution
- Product was distributed to 3 consignees in Florida and Wisconsin.
- Lot, serial or model codes
- Codes HZ5071, HZ59014 and HZ59017.
- 510(k) numbers
- ["K071360"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28