Varian Medical Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0607-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 28, 2012

Date Posted: December 26, 2012

Recall Number: Z-0607-2013

Event ID: 63667

Reason for Recall:

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

Status: Terminated

Product Quantity: 15 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated