FDA Device recall Z-2840-2018
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infin…
- FDA Device
- Class II
- terminated
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class II recall of ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infin… by Elekta, citing there is a potential for an uncontrolled extension of iViewGT / XVI detector arms.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2840-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-01 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | US |
Product
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
Reason
There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.
Identifiers
| code_info | All Digital Accelerators with XVI or iViewGT |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2840-2018%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.