Z-1324-2013 Class II Terminated
FDA device recall Z-1324-2013 was initiated by Varian Medical Systems, Inc. on April 11, 2013 and is designated Class II. Reason for recall: Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target. The recall status is terminated (terminated January 13, 2014). Affected quantity: 21 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2013
- Initiation Date
- April 11, 2013
- Termination Date
- January 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 devices
Product Description
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
Reason for Recall
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
Distribution Pattern
Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
Code Information
Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387