FDA Device

X80 RADiant Photoelectric Therapy System

Hazard

There is a potential compatibility issue with the systems and replacement treatment applicators.

What You Should Do

Remedy

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.

Products

X80 RADiant Photoelectric Therapy System
Brand
Xstrahl Limited
UPC
Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008

Units Affected

7 devices; 70 treatment applicators