FDA Device recall Z-0389-2022
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
- FDA Device
- Class II
- terminated
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system by Xstrahl, citing base plate may detach from the main body of the treatment applicator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0389-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-27 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Xstrahl |
| Distribution | n/a |
Product
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Reason
Base plate may detach from the main body of the treatment applicator.
Identifiers
| code_info | GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506 |
|---|
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-0389-2022%22
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