FDA Device recall Z-1404-2022
X80 RADiant Photoelectric Therapy System
- FDA Device
- Class II
- ongoing
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of X80 RADiant Photoelectric Therapy System by Xstrahl, citing there is a potential compatibility issue with the systems and replacement treatment applicators.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1404-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-27 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Xstrahl |
| Distribution | CA, FL, KY |
Product
X80 RADiant Photoelectric Therapy System
Reason
There is a potential compatibility issue with the systems and replacement treatment applicators.
Identifiers
| code_info | Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008 |
|---|
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-1404-2022%22
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