FDA Medical Device Recalls (openFDA)
Varian Medical Systems Inc: medical device and software systems
- Recall number
- Z-1314-04
- Recalling firm
- Varian Medical Systems Inc
- Product
- medical device and software systems
- Status
- Terminated
- Initiated
- 2004-06-24
- Posted
- 2004-08-07
- Terminated
- 2004-12-23
- Reason
- a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session.
- Root cause
- Other
- Action
- Notification letter to consignees sent 06/14/2004.
- Quantity
- 28 units
- Distribution
- produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign
- Lot, serial or model codes
- Version Numbers 6.2.27 and 6.2.35, 510k number K001643, serial numbers H8__ (31901, 50044, 50149, 50181, 50187,50260, 50284, 50315, 50357, 50397, 50430, 50804, 50873, 51096, 51152, 51186, 51082, 51463, 51534, 51580, 51658, 51773, 51787, 59032, 59040, 59041, 59045)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MUJ
- 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