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.
Reported: December 26, 2012 Initiated: September 28, 2012 #Z-0607-2013
Product Description
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.
Details
- Recalling Firm
- Varian Medical Systems, Inc.
- Units Affected
- 15 units
- Distribution
- Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.
- Location
- Charlottesville, VA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Varian Medical Systems, Inc.. Units affected: 15 units.
Why was this product recalled? ▼
The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2012. Severity: Moderate. Recall number: Z-0607-2013.
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