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Recall Observatory FDA recall evidence

Device product

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

Z-0389-2022

August 27, 2021

Class II

Product summary

Firm
Xstrahl Limited
Event
Event 88545
Status
Terminated
Classification
Class II
Quantity
120 applicators
Official record key
device-enforcement:Z-0389-2022

Official wording

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

Code information: GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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