Recall Z-1404-2022— Xstrahl Limited

Name: FDA recall Z-1404-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-27

Class II · Ongoing

Class II FDA medical device recall by Xstrahl Limited, initiated 2022-04-27. It names one FDA 510(k) clearance: K172080. Product: X80 RADiant Photoelectric Therapy System. Reason: There is a potential compatibility issue with the systems and replacement treatment applicators..

Recalling firm: Xstrahl Limited
Classification: Class II
Status: Ongoing
Initiated: 2022-04-27
Firm location: Walsall, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K172080 — Photoelectric Therapy SystemXstrahl, Ltd.·cleared 2017-09-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

X80 RADiant Photoelectric Therapy System

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.