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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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.
Related recalls
Same manufacturer · Varian Medical Systems Inc
See all →- HighVarian Multileaf Collimator Recall Due to Software-Related Leaf Movement Failure
FDA (Devices) · 2020-05-13
- HighVarian Eclipse Treatment Planning System Proton Algorithm Recall
FDA (Devices) · 2019-01-30
- HighVarian Eclipse Treatment Planning System Software Recall for Contouring Errors
FDA (Devices) · 2017-01-18
- HighVarian Head Frame Posts Recalled Due to Rotation Risk
FDA (Devices) · 2016-10-19
- HighVarian Optical Surface Monitoring System Recall for Unintended Couch Parameter Changes
FDA (Devices) · 2016-07-20
Similar recalls
- HighVarian Segmented Cylinder Applicator Set Recalled for Potential Slippage During Treatment
FDA (Devices) · 2013-05-22
- HighVarian Medical Systems Recalls Titanium Rectal Retractors for Brachytherapy
FDA (Devices) · 2013-02-06
- HighVarian Medical Rectal Retractors Recalled for Contamination Risk
FDA (Devices) · 2013-02-06
- HighVarian VariSource iX Afterloader Systems Recalled for Calculation Errors
FDA (Devices) · 2015-07-08
- HighVarian AlignRT Plus Optical Surface Monitoring System Recall for Parameter Errors
FDA (Devices) · 2016-07-20
- ModerateSiemens Dimension Vista Prolactin Reagent Cartridge Recall for Labeling Error
FDA (Devices) · 2017-06-28