FDA Device recall Z-0706-2019
Elekta Unity
- FDA Device
- Class II
- completed
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class II recall of Elekta Unity by Elekta, citing in rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the spea….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0706-2019 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-01-04 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta |
| Distribution | TX, WI |
Product
Elekta Unity
Reason
In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.
Identifiers
| code_info | Serial Numbers: 1536549, 1536549 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0706-2019%22
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