Food, drugs, devices › Xstrahl Limited
Device recall: X80 RADiant Photoelectric Therapy System
Xstrahl Limited (Walsall, N/A) initiated this device recall on 27 Apr 2022; FDA lists 1 product record under event 90231, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Xstrahl Limited has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Xstrahl Limited, Walsall, N/A, United Kingdom.
Reason for recall
"There is a potential compatibility issue with the systems and replacement treatment applicators."
Distribution
"US Distribution FL, CA, KY"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1404-2022 | X80 RADiant Photoelectric Therapy System | 7 devices; 70 treatment applicators | Class II | Ongoing | 27 Jul 2022 |
Context
Other enforcement events for Xstrahl Limited
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Aug 2021 | Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system | Device | Class II | 1 |
| 26 Apr 2021 | Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV S | Device | Class II | 1 |
All 3 events for Xstrahl Limited
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is a potential compatibility issue with the systems and replacement treatment applicators."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution FL, CA, KY"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.