FDA Device recall Z-0607-2013
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube fo…
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube fo… by Varian Medical Systems, citing the guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0607-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-28 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems |
| Distribution | GA |
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
The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
Identifiers
| code_info | Lot L33, Serial numbers H64Y009-GM, H64A056, H640576, H600272, H640784, H640774, H640764, H600603, H640547, |
|---|
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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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0607-2013%22
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