Xstrahl Limited: Medical Device Recall in 2022 - (Recall #: Z-1404-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

X80 RADiant Photoelectric Therapy System

Product Classification:

Class II

Date Initiated: April 27, 2022

Date Posted: July 27, 2022

Recall Number: Z-1404-2022

Event ID: 90231

Reason for Recall:

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

Status: Ongoing

Product Quantity: 7 devices; 70 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

Voluntary or Mandated:

Voluntary: Firm initiated