FDA Device recall Z-0115-2022
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143
- FDA Device
- Class II
- terminated
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143 by Elekta Solutions Ab, citing there is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0115-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-28 |
| Published | 2021-10-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Elekta Solutions Ab |
| Distribution | NC, ND |
Product
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Reason
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
Identifiers
| code_info | Elekta Harmony Pro, Serial #441009, UDI (01) 05060191071604; Elekta Infinity, Serial #156645, UDI (01) 05060191071543;…Elekta Harmony Pro, Serial #441009, UDI (01) 05060191071604; Elekta Infinity, Serial #156645, UDI (01) 05060191071543; and Elekta Versa HD, Serial #156646, #156477, and #156648, UDI (01) 05060191071574 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0115-2022%22
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