Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
FDA Recall Z-0389-2022 · Posted None
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Recalling FirmXstrahl Limited
Recall StatusTerminated
Product CodeJAD
Date Initiated2021-08-27
Date Terminated2026-03-04
Product Quantity120 applicators
Reason for Recall
Base plate may detach from the main body of the treatment applicator.
Firm Action
The firm notified their consignees by email on 08/27/2021. The notice requested the following actions be taken:
Xstrahl Limited are issuing the following inspection advice for all X150 specifical system users.
1. Prior to any clinical exposure the operator of the system should inspect the treatment applicator prior to inserting it into the treatment head of the X150.
2. As part of the daily assurance process the treatment applicators should be inspected.
3. If a treatment applicator is dropped it should be inspected by medical physics to ensure it is not damaged.
4. If the base plate is missing the applicators must be withdrawn from clinical use until it is repaired and accepted by medical physics.
5. In the case of an applicator where the base plate has become detached, review the prescription history for the patients for whom that applicator was prescribed.
6. Please advise Xstrahl Limited if you believe patients have been treated with a base plate missing, with detail of the applicator size and clinical filter, kV and HVL, and we will contact you directly.
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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