Z-1829-2015Class II

Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set

Name: Z-1829-2015 Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set
Creator: Varian Medical Systems Inc
Published: 2015-05-18
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2015-05-18 / Terminated / root cause: manufacturing process

FDA source

Varian Medical Systems Inc began a recall of Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set on 2015-05-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1829-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-18
Posted: 2015-06-23
Terminated: 2016-01-26
Recalling firm: Varian Medical Systems, Inc.
Product: Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 46
Distribution: Worldwide Distribution.
Product codes and lots: JAQ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1829-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1829-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-23

Product code JAQ

K123815Class IISurface Applicator Set with Leipzig-Style ConeVarian Medical Systems, Inc. / cleared 2013-03-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)