Z-3055-2011

Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set...

Name: Z-3055-2011 Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set...
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2011-07-13
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2011-07-13 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal... on 2011-07-13. The reason FDA records is "Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3055-2011
Status: Terminated
Initiated: 2011-07-13
Posted: 2011-08-22
Terminated: 2012-06-20
Recalling firm: Varian Medical Systems, Inc.
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.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error.
Root cause tag: design
FDA 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 in commerce: 1019 total
Distribution: Worldwide Distribution
Product codes and lots: Part number GM11002420; (part of Segmented Cyclinder Set, GM11004150). All lots.

Product code JAQ

K033371Class IIVarian Intracavitary Brachytherapy ApplicatorsVarian Medical Systems / cleared 2003-12-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)