[Recalled] Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system — Base plate may detach from the main body of the treatment applicator | FDA 2021-08-27
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system |
|---|---|
| Brand / manufacturer | Xstrahl Limited |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0389-2022 |
| Country of notice | United Kingdom |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 27 August 2021 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Base plate may detach from the main body of the treatment applicator.
This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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