FDA Device recall Z-1829-2015
Surface Applicator Set with Leipzig-style Cone
- FDA Device
- Class II
- terminated
- Published 2015-07-01
On 2015-07-01 the FDA classified a Class II recall of Surface Applicator Set with Leipzig-style Cone by Varian Medical Systems, citing 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 GM1….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1829-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-18 |
| Published | 2015-07-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems |
| Distribution | n/a |
Product
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Reason
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
Identifiers
| code_info | JAQ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Varian Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1829-2015%22
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