FDA Medical Device Recalls (openFDA)
Varian Medical Systems Inc: Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
- Recall number
- Z-1829-2015
- Recalling firm
- Varian Medical Systems Inc
- Product
- Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
- Status
- Terminated
- Initiated
- 2015-05-18
- Posted
- 2015-06-23
- Terminated
- 2016-01-26
- Reason
- Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat
- Root cause
- Process design
- Action
- All the consignees affected by this recall will be notified by: The Urgent Medical Device Correction Letter/ Field Safety Notification will be distributed to all affected users, with a description of the problem. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. Additionally, the letter will be posted to the customer support site: http:/ /www.MyVarian.com.
- Quantity
- 46
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- JAQ
- 510(k) numbers
- ["K123815"]
- PMA numbers
- not on file
- Product code
- JAQ
- Firm FEI
- 3011400544
- 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