FDA Device recall Z-2567-2014
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX,…
- FDA Device
- Class II
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class II recall of C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX,… by Varian Medical Systems, citing trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2567-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-17 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems |
| Distribution | US |
Product
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Reason
Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
Identifiers
| code_info | Model numbers HCX, H14, H27, H29. Serial numbers: H140001 H140152 H140724 H140791 H140857 H140924 H140985 H2712…Model numbers HCX, H14, H27, H29. Serial numbers: H140001 H140152 H140724 H140791 H140857 H140924 H140985 H271272 H271729 H272009 H272180 H272353 H272819 H140011 H140201 H140725 H140792 H140858 H140925 H140986 H271276 H271755 H272014 H272181 H272354 H272820 H140018 H140202 H140727 H140793 H140859 H140926 H140987 H271293 H271759 H272015 H272187 H272359 H272822 H140025 H140203 H140728 H140795 H140860 H140927 H140988 H271308 H271762 H272016 H272188 H272362 H272824 H140026 H140204 H140729 H140796 H140861 H140928 H140989 H271330 H271763 H272018 H272195 H272365 H272825 H140027 H140206 H140730 H140797 H140863 H140930 H140990 H271334 H271773 H272022 H272197 H272370 H272826 H140029 H140207 H140732 H140799 H140864 H140931 H140991 H271385 H271783 H272023 H272198 H272377 H272828 H140036 H140208 H140733 H140800 H140865 H140932 H140992 H271400 H271785 H272024 H272201 H272382 H272834 H140038 H140 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2567-2014%22
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