Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall X80 RADiant Photoelectric Therapy System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall X80 RADiant Photoelectric Therapy System see related information
Date Initiated by Firm April 27, 2022
Create Date July 19, 2022
Recall Status1 Open3, Classified
Recall Number Z-1404-2022
Recall Event ID 90231
510(K)Number K172080  
Product Classification System, therapeutic, x-ray - Product Code JAD
Product X80 RADiant Photoelectric Therapy System
Code Information Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008
Recalling Firm/
Manufacturer		 Xstrahl Limited
Unit 2
Maybrook Industrial Estate Maybro; Maybrook Road
Walsall United Kingdom
Manufacturer Reason
for Recall		 There is a potential compatibility issue with the systems and replacement treatment applicators.
FDA Determined
Cause 2		 Finished device change control
Action The firm sent out the recall notification on 04/27/2022 via email. The letter mentions the consignee is able to continue to use the system. The consignee is to ensure that the verification of selection of the correct applicator for the planned treatment is conducted with the consignee's procedures and radiotherapy professional practice and guidelines. They are asked to complete a response form and return it no later than 30 days.
Quantity in Commerce 7 devices; 70 treatment applicators
Distribution US Distribution FL, CA, KY
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAD and Original Applicant = Xstrahl Ltd.
-
-