Surface Applicator Set with Leipzig-style Cone — Class II medical device recall Z-1829-2015
Terminated recall by Varian Medical Systems Inc, reported 2015-07-01. Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surfa
| Recall number | Z-1829-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems Inc, Charlottesville, VA, United States |
| Recall initiated | 2015-05-18 |
| Classified | 2015-06-23 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2016-01-26 |
| Quantity | 46 |
Product
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1829-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.