Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 22, 2021
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Xstrahl Limited recalled Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy syst… - a moderate-severity action.
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy syst… was recalled by Xstrahl Limited in December 22, 2021. Reason: Base plate may detach from the main body of the treatment applicator.. Check the official notice for the remedy. Verify recall #Z-0389-2022 with the FDA Devices before acting.
The recall
Xstrahl Limited issued this moderate-severity FDA Devices recall-Base plate may detach from the main body of the treatment applicator..
- Moderate
- severity level
- Class II
- classification
- December 22, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0389-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0389-2022) was formally reported on December 22, 2021, with the manufacturer initiating the action on August 27, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Xstrahl Limited is listed as the recalling firm, operating out of Walsall. Federal records list the affected scope as 120 applicators.
The documented reason for this recall is: Base plate may detach from the main body of the treatment applicator. Distribution data in the federal record shows the product reached: US and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA, CYPRUS, DENMARK, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KAZAKHSTAN, LATVIA, MALTA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, ROMANIA, RUSSIA, SA…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
120 applicators
Related Recalls
6
3 from same agency
Product description
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Reason for recall
Base plate may detach from the main body of the treatment applicator.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0389-2022 |
| Date reported | December 22, 2021 |
| Date initiated | August 27, 2021 |
| Recalling firm | Xstrahl Limited |
| Firm location | Walsall |
| Affected scope | 120 applicators |
| Distribution | US and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA, CYPRUS, DENMARK, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KAZAKHSTAN, LATVIA, MALTA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, ROMANIA, RUSSIA, SAUDI ARABIA, SPAIN, S… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0389-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system. Recalled by Xstrahl Limited. Units affected: 120 applicators.
Why was this product recalled? ▼
Base plate may detach from the main body of the treatment applicator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 22, 2021. Severity: Moderate. Recall number: Z-0389-2022.
Where was the recalled product distributed? ▼
Distribution: US and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA, CYPRUS, DENMARK, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KAZAKHSTAN, LATVIA, MALTA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, ROMANIA, RUSSIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UK, UKRAINE.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0389-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 22, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.