FDA Device recall Z-2473-2020
Elekta Unity, Image-Guided Radiation Therapy System
- FDA Device
- Class II
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of Elekta Unity, Image-Guided Radiation Therapy System by Elekta, citing there have been reports of excessive heating in the MRL Gradient Connection Module.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2473-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-18 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta |
| Distribution | IA, NY, PA |
Product
Elekta Unity, Image-Guided Radiation Therapy System
Reason
There have been reports of excessive heating in the MRL Gradient Connection Module.
Identifiers
| code_info | Elekta Unity Serial numbers 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 6…Elekta Unity Serial numbers 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, 600035 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2473-2020%22
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