FDA Medical Device Recalls (openFDA)
Varian Brachytherary Virginia: BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***
- Recall number
- Z-0176-03
- Recalling firm
- Varian Brachytherary Virginia
- Product
- BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***
- Status
- Terminated
- Initiated
- 2003-10-31
- Posted
- 2003-12-03
- Terminated
- 2003-12-15
- Reason
- The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient.
- Root cause
- Other
- Action
- The recalling firm notified consignees by Customer Technical Bulletin on 5/21/03 and additionally by 'URGENT MEDICAL DEVICE CORRECTION LETTER' on 10/31/03. The notifications caution consignees about the need to fully understand scaling functionality and to check scaling for every treatment plan. The notification further explains that the next software release will be modified to include a screen message that appears whenever automatic magnification appears.
- Quantity
- 29 sets
- Distribution
- Software was distributed to end users nationwide and internationally.
- Lot, serial or model codes
- Versions 6.1 and 6.5
- 510(k) numbers
- ["K992762"]
- PMA numbers
- not on file
- Product code
- LNX
- Firm FEI
- 3000206172
- Firm city
- Charlottesville
- Firm state
- VA
- 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