FDA Device recall Z-0439-2014
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator
- FDA Device
- Class II
- terminated
- Published 2013-12-11
On 2013-12-11 the FDA classified a Class II recall of C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator by Varian Medical Systems, citing this correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0439-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-24 |
| Published | 2013-12-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems |
| Distribution | US |
Product
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Reason
This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.
Identifiers
| code_info | Model numbers Hl4, HIS, H27, H29: Serial numbers: H140001 H140136 H140700 H140759 Hl40817 H140875 Hl40937 H14099…Model numbers Hl4, HIS, H27, H29: Serial numbers: H140001 H140136 H140700 H140759 Hl40817 H140875 Hl40937 H140995 Hl82047 H271330 H271664 H271935 H272132 H140011 Hl40137 H140701 H140760 Hl40818 H140876 Hl40938 H140996 Hl82048 H271334 H271666 H271938 H272134 H140018 H140138 Hl40702 H140761 Hl40819 Hl40877 H140939 H140997 Hl82049 H271344 H271669 H271942 H272136 Hl40025 H140139 Hl40703 Hl40762 Hl40820 H140878 H140940 Hl40998 Hl82050 H271362 H271678 H271951 H272137 Hl40026 H140140 Hl40704 Hl40763 H140821 H140879 H140941 H140999 Hl820Sl H271370 H271681 H271954 H272138 Hl40027 Hl40141 Hl40705 Hl40764 H140822 Hl40880 H140942 Hl41000 Hl82054 H271378 H271691 H271958 H272143 H140029 H140142 Hl40706 Hl4076S H140823 H140881 H140943 Hl41001 Hl820SS H27138S H271693 H271959 H272144 Hl40036 H140143 Hl40707 Hl40766 H140824 H140882 H140944 H141002 H182056 H271393 H271711 H271961 H27214S H140038 H140144 H140708 H140767 H14082S H140883 H14094S H141003 Hl82057 H271398 H271712 H271964 H272146 |
|---|
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-0439-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.