Z-1404-2022Class II

X80 RADiant Photoelectric Therapy System

Name: Z-1404-2022 X80 RADiant Photoelectric Therapy System
Creator: Xstrahl Limited
Published: 2022-04-27
License: https://open.fda.gov/license/

Xstrahl Limited / initiated 2022-04-27 / Open, Classified

FDA source

Xstrahl Limited began a recall of X80 RADiant Photoelectric Therapy System on 2022-04-27. FDA classified it as Class II and gives the reason as "There is a potential compatibility issue with the systems and replacement treatment applicators". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1404-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-27
Posted: 2022-07-19
Recalling firm: Xstrahl Limited
Product: X80 RADiant Photoelectric Therapy System
Product code: JAD System, Therapeutic, X-Ray
Reason for recall: There is a potential compatibility issue with the systems and replacement treatment applicators.
FDA root cause: 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
Product codes and lots: Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1404-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1404-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-19

Product code JAD

K172080Class IIPhotoelectric Therapy SystemXstrahl, Ltd. / cleared 2017-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)