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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAD
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