FDA Medical Device Recalls (openFDA)
Varian Medical Systems Inc: Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX)
- Recall number
- Z-0194-2007
- Recalling firm
- Varian Medical Systems Inc
- Product
- Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX)
- Status
- Terminated
- Initiated
- 2006-08-31
- Posted
- 2006-11-16
- Terminated
- 2007-12-04
- Reason
- The chain holding the device gantry in position may break.
- Root cause
- Process control
- Action
- On 8/31/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
- Quantity
- 254 units
- Distribution
- Worldwide, including USA, England, Taiwan, Switzerland, Sweden, South Korea, Portugal, Poland, Norway, New Zealand, Netherlands, Malaysia, Japan, Italy, Germany, France, Denmark, Czech Republic, Colombia, China, Canada, Belgium, Australia and Venezuela.
- Lot, serial or model codes
- Serial numbers H272325, H291060, H271879, H273040, H272187, H272434
- 510(k) numbers
- ["K904264","K913119"]
- 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