FDA Medical Device Recalls (openFDA)
Varian Medical Systems Oncology Systems: Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA
- Recall number
- Z-1003-2011
- Recalling firm
- Varian Medical Systems Oncology Systems
- Product
- Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA
- Status
- Terminated
- Initiated
- 2010-04-19
- Posted
- 2011-02-01
- Terminated
- 2011-12-23
- Reason
- The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.
- Root cause
- Labeling mix-ups
- Action
- Varian issued via customer technical bulletin on April 19, 2010, to Varian Sales, Marketing and Service organization. Notification. The bulletin identified the product, the problem, and the action to be taken by the customer. Customers were asked to fill out the attached form and send it to their local Varial Medical Systems Field Service Office. For questions regarding this recall call 650-483-3153.
- Quantity
- 13
- Distribution
- Worldwide Distribution - Japan only
- Lot, serial or model codes
- Product Codes: H690002, H694936, H696287, H695791, H694466, H696406, H694937, H697423, H695540, H695617, H695747, H695780, H696166
- 510(k) numbers
- ["K033339","K904364"]
- 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