FDAClass IIDecember 22, 2021

Treatment applicator for Gulmay Medical 150 or Xstrahl recall

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

Why was Treatment applicator for Gulmay Medical 150 or Xstrahl recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Recalling firm
Xstrahl Limited
Quantity
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, SWEDEN, SWITZERLAND, UK, UKRAINE
Recall date
December 22, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls