Segmented Cylinder Applicator Set — Class II medical device recall Z-1324-2013
Terminated recall by Varian Medical Systems, Inc., reported 2013-05-22, distributed nationwide. Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outsid
| Recall number | Z-1324-2013 |
|---|---|
| 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 | 2013-04-11 |
| Classified | 2013-05-14 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2014-01-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, FR, GB, SE, SI |
| Quantity | 21 devices |
| Serial numbers | H640277, H640303, H640372, H640383, H640384, H640385, H640387, H640788, H640D126 |
| Model numbers | GM11004150 |
Product
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
Reason for recall
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
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-1324-2013. 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.