RecallRadar

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…

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

AgencyFDA Device
Recall numberZ-0607-2013
ClassificationClass II
Statusterminated
Initiated2012-09-28
Published2012-12-26
Last updated2026-09-13 11:53 UTC
CompanyVarian Medical Systems
DistributionGA

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_infoLot 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.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0607-2013%22

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