Z-1404-2022 Class II Ongoing

Recalled by Xstrahl Limited — Walsall, N/A

Recall Details

Product Type
Devices
Report Date
July 27, 2022
Initiation Date
April 27, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7 devices; 70 treatment applicators

Product Description

X80 RADiant Photoelectric Therapy System

Reason for Recall

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

Distribution Pattern

US Distribution FL, CA, KY

Code Information

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