Xstrahl Limited
Xstrahl Limited has 3 FDA enforcement events on this register (3 product records) between 2021 and 2022: 3 device; the busiest year was 2021 with 2.
0% of its events are Class I; the most common class is Class II (3). 1 event is listed as ongoing; the recalling firm's address is in N/A.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 27 Apr 2022 | X80 RADiant Photoelectric Therapy System | Device | Class II | 1 | Ongoing |
| 27 Aug 2021 | Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system | Device | Class II | 1 | Terminated |
| 26 Apr 2021 | Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System; (4)… | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Xstrahl Limited had?
3 enforcement events (3 product records) on this register, 2021–2022: 3 device.
Are any Xstrahl Limited recalls ongoing?
1 event is listed as ongoing in the current openFDA export.
What class are Xstrahl Limited recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.