Segmented Cervix Applicator Set — Class II medical device recall Z-0607-2013
Terminated recall by Varian Medical Systems, Inc., reported 2012-12-26, distributed in GA. The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical s
| Recall number | Z-0607-2013 |
|---|---|
| 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 | 2012-09-28 |
| Classified | 2012-12-20 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-04-02 |
| Distributed | GA |
| Countries outside the US | CA, DE, IN, PL, TH |
| Quantity | 15 units |
| Lot numbers | L33 |
| Serial numbers | H600272, H600603, H640547, H640576, H640764, H640774, H640784, H64A056, H64Y009-GM |
| Model numbers | GM11004310 |
Product
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.
Reason for recall
The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
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-0607-2013. 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.