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Recall Observatory FDA recall evidence

Device 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.

Z-0607-2013

September 28, 2012

Class II

Product summary

Firm
Varian Medical Systems, Inc.
Event
Event 63667
Status
Terminated
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-0607-2013

Official wording

Reason: The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.

Code information: Lot L33, Serial numbers H64Y009-GM, H64A056, H640576, H600272, H640784, H640774, H640764, H600603, H640547,

Distribution pattern: Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.