Recall Z-0607-2013— Varian Medical Systems, Inc.

Name: FDA recall Z-0607-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-28

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2012-09-28, terminated 2013-04-02. It names one FDA 510(k) clearance: K983436. 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..

Recalling firm: Varian Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-09-28
Terminated: 2013-04-02
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K983436 — GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEMGammamed USA·cleared 1998-10-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.