FDA Medical Device Recalls (openFDA)
Varian Medical Systems, Inc. Oncology Systems: Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.
- Recall number
- Z-3055-2011
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Product
- Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.
- Status
- Terminated
- Initiated
- 2011-07-13
- Posted
- 2011-08-22
- Terminated
- 2012-06-20
- Reason
- Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error.
- Root cause
- Device Design
- Action
- Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to locate old design applicator probes and guiding tubes and to cease use of the affected products. Information in the letter included instructions on how to return the products to Varian BrachyTherapy. Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice.
- Quantity
- 1019 total
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Part number GM11002420; (part of Segmented Cyclinder Set, GM11004150). All lots.
- 510(k) numbers
- ["K033371"]
- PMA numbers
- not on file
- Product code
- JAQ
- 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
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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