Use caution Medical device recall · FDA · Published August 27, 2021

Xstrahl 150 Treatment Applicator Recall: Base Plate May Detach

Xstrahl Limited recalls 150-series superficial X-ray therapy systems due to risk of base plate detaching from the main body. Affected models include GM0072 through GM0506. Contact for repair or return.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0389-2022Medical device Xstrahl ›

Use caution until it’s fixed

Base plate may detach from the main body of the treatment applicator.

Take action

Contact the company

Recalling firmXstrahl LimitedUnit 2, Maybrook Industrial Estate Maybro; Maybrook Road · Walsall, United Kingdom

✎ GovInfoNow plain-language explainer

Xstrahl Limited is recalling certain 150-series superficial X-ray therapy systems because the base plate might detach from the main body. This could cause injury if the device moves unexpectedly during treatment. Read more at govinfonow.com/recall/61879-xstrahl-150-treatment-applicator-recall-base-plate-may-detach.

Source Summary by GovInfoNow · govinfonow.com/recall/61879-xstrahl-150-treatment-applicator-recall-base-plate-may-detach · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0389-2022

Cite this page

“Xstrahl 150 Treatment Applicator Recall: Base Plate May Detach.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61879-xstrahl-150-treatment-applicator-recall-base-plate-may-detach. Based on FDA recall #Z-0389-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0389-2022%22&limit=1).

The Food and Drug Administration announced on Aug. 27, 2021, that Xstrahl Limited voluntarily recalled treatment applicators for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy systems because the base plate may detach from the main body. The agency issued recall number Z-0389-2022.

How to tell if you have it

Brand: Xstrahl
Product: Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Model numbers: GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506
Quantity: 120 applicators

The hazard

The base plate may detach from the main body of the treatment applicator.

Context

GovInfoNow's records show Xstrahl Limited has two other recalls on record since April 26, 2021. On April 27, 2022, the company recalled the X80 RADiant Therapy System due to potential compatibility issues with applicators. On April 26, 2021, Xstrahl recalled Concerto Software because a saved treatment plan with two opposing beams might not update Beam 2 parameters upon saving. Other recent recalls of similar products include the Stryker XCEL Bladeless Trocar W/Stability Sleeve 12x100mm (Aug. 19, 2026) and the Canon Alphenix X-ray Systems (Aug. 4, 2026).

How to tell if you have this one

Check if your Xstrahl 150 or Gulmay Medical 150 superficial X-ray therapy system has a model number from GM0072 to GM0506. The product was sold with these specific model numbers.

Brand
Xstrahl
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Identify your device's model number to confirm if it is in the recall list (GM0072 through GM0506).
Contact Manufacturer
Reach out to Xstrahl Limited for instructions on repair or return of the affected device.

How this recall unfolded

Recall timeline

FDA terminated this recall 4.5 years after the firm started it.

Aug 27, 2021Firm started the recall
Dec 16, 2021FDA classified it Class II
Dec 22, 2021Published in FDA’s Enforcement Report
Mar 4, 2026FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What model numbers are affected?

Model numbers GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506.

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Link to this recall

<a href="https://govinfonow.com/recall/61879-xstrahl-150-treatment-applicator-recall-base-plate-may-detach">Xstrahl 150 Treatment Applicator Recall: Base Plate May Detach (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0389-2022 (August 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0389-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.