Xstrahl Limited X80 RADiant Photoelectric Therapy System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
X80 RADiant Photoelectric Therapy System
Brand
Xstrahl Limited
Lot Codes / Batch Numbers
Model Number: X80 RADiant Photoelectric Therapy System, Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577, UDI/DI: 5060494200008
Products Sold
Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008
Xstrahl Limited is recalling X80 RADiant Photoelectric Therapy System due to There is a potential compatibility issue with the systems and replacement treatment applicators.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential compatibility issue with the systems and replacement treatment applicators.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, KY
Page updated: Jan 10, 2026