FDA Device recall Z-1665-2023
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity
- FDA Device
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity by Elekta, citing A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1665-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-05 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Elekta |
| Distribution | AR, IN, LA, OK, TN, VA, WA |
Product
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Reason
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
Identifiers
| code_info | Varex Part Number 95510354H-01 (Varex serial numbers 354-01H_A0010004PC to 354-01H_A0010269PC). a. Elekta Infinity: UD…Varex Part Number 95510354H-01 (Varex serial numbers 354-01H_A0010004PC to 354-01H_A0010269PC). a. Elekta Infinity: UDI-DI Number: 05060191071543, 05060191071512 (Serial Numbers: 156073, 152223, 153681); b. Versa HD: UDI-DI Number: 05060191071574, 05060191071529 (Serial Numbers: 156941, 156989, 156724, 156998); c. Elekta Synergy: UDI-DI Number: 05060191071550, 05060191071505 (Serial Number: 152483) Additional serial numbers distributed OUS: 109331, 109333, 109335, 109336, 109339, 109341, 109342, 151879, 152194, 153038, 153299, 153410, 153970, 156841, 156849, 156966, 156968, 156969, 156970, 156971, 156973, 156977, 156978, 156979, 156980, 156981, 156982, 156983, 156984, 156985, 156986, 156987, 156988, 156990, 156992, 156995, 156996, 156997. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1665-2023%22
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