Z-1324-2013Class II

Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR)

Name: Z-1324-2013 Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR)
Creator: Varian Medical Systems, Inc.
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. began a recall of Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to.... FDA classified it as Class II and gives the reason as "Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target". 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-1324-2013
Classification: Class II
Status: Terminated
Posted: 2013-05-15
Terminated: 2014-01-13
Recalling firm: Varian Medical Systems, Inc.
Product: Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
Root cause tag: design
FDA root cause: Device Design
Action: Varian Medical Systems, Inc. notified customers of the recall with 'Urgent Medical Device Correction Urgent Field Safety Notice," dated 4/11/13, and delivered by mail to customers. The notice identified the product, problem, and instructions for the customers. Varian Medical Systems, Inc. informed customers of the possible malfunction of the GM11004150 Segmented Cylinder Applicator Set for pulsed dose rate brachytherapy treatment, with codes H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387. The notice instructed customers to cease use of the Segmented Cylinder Applicator Set and return the devices along with a completed proof of notification form (included with the recall notice) to the recalling firm.
Quantity in commerce: 21 devices
Distribution: Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
Product codes and lots: Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1324-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1324-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-14

Product code JAQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)