Device product

X80 RADiant Photoelectric Therapy System

Z-1404-2022

April 27, 2022

Class II

Product summary

Firm: Xstrahl Limited
Event: Event 90231
Status: Ongoing
Classification: Class II
Quantity: 7 devices; 70 treatment applicators
Official record key: device-enforcement:Z-1404-2022

Official wording

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

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

Distribution pattern: US Distribution FL, CA, KY

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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