CLASS II Device recall · Reported 1 Jul 2015 · FDA Enforcement Report

Surface Applicator Set with Leipzig-style Cone recalled

Varian Medical Systems is recalling Surface Applicator Set with Leipzig-style Cone. The recall was initiated on 18 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesJAQ

Quantity recalled46

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1829-2015
FDA event ID: 71450
Recalling firm: Varian Medical Systems, Charlottesville, VA
Classification: Class II
Status: Terminated
Recall initiated: 18 May 2015
FDA classified: 23 Jun 2015
Reported: 1 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 May 2015	Recall initiated by company
23 Jun 2015	Classified by FDA	+36 days
1 Jul 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution.

Questions about this recall

Is Surface Applicator Set with Leipzig-style Cone recalled?

Yes. Varian Medical Systems recalled Surface Applicator Set with Leipzig-style Cone on 18 May 2015. The recall is Class II and its status is Terminated. Recall number Z-1829-2015.

Why was it recalled?

Which lots are affected?

JAQ

Where was it sold?

Worldwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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