The Recall Desk
HighFDA (Devices)·Z-1829-2015·Announced 2015-07-01

Varian Leipzig-style Brachytherapy Applicator Set Recalled for Dose Rate Discrepancy

Varian Medical Systems is recalling 46 Leipzig-style Surface Applicator Sets because the actual dose rate is approximately 14% higher than the rate published in the Instructions for Use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where the actual dose rate is significantly higher than documented, posing a risk of harm through incorrect radiation dosing, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Varian Medical Systems Inc is recalling 46 units of the Surface Applicator Set with Leipzig-style Cone, a brachytherapy applicator set. The recall is due to a discrepancy in the absolute dose rate provided in the Instructions for Use (IFU) document GM11010080, dated 2012-09-06.

The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. The source text indicates that using the dose rate as provided by the IFU without modification or independent confirmation may lead to incorrect dosing.

The affected products were distributed worldwide. Healthcare providers and users of these applicator sets should stop using the affected units and contact Varian Medical Systems for further instructions.

The recalled product

Product
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Manufacturer
Varian Medical Systems Inc
Category
Medical Device — Radiation Therapy
Hazard
Affected units
46

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • JAQ

Distribution

Distribution scope not specified by the agency.

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