Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Summary
The FDA issued a Class II for Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray the by Xstrahl Limited. Reason: Base plate may detach from the main body of the treatment applicator..
Details
Source
Device Recall
External ID
Z-0389-2022
Action Date
2021-12-22
Status
Terminated
Category
device
Product Description
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Lot/Code Info: GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506
Quantity Affected: 120 applicators
Reason for Recall
Base plate may detach from the main body of the treatment applicator.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-27
Company
Walsall
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Xstrahl Limited has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Xstrahl Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Xstrahl Limited have FDA actions?
Xstrahl Limited has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0389-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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