FDA Device recall Z-1324-2013
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose r…
- FDA Device
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose r… by Varian Medical Systems, citing segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1324-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-11 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems |
| Distribution | US |
Product
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
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
Identifiers
| code_info | Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Varian Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1324-2013%22
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