Reported Dec 22, 2021 · Terminated

Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system

Xstrahl Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Xstrahl Limited · Unit 2 · Walsall · N/A

Is this the product you have?

  • Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Lot codes and dates
    • GM0072
    • GM0077
    • GM0086
    • GM0117
    • GM0131
    • GM0158
    • GM0184
    • GM0189
    • GM0275
    • GM0307
    • GM0338
    • GM0379
    • GM0414
    • GM0469
    • GM0506
Amount recalled
120 applicators

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 4, 2026 · Data as of Sep 19, 5:39 PM UTC

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