Medical device recalls Moderate risk

Xstrahl Limited recalls X80 RADiant Photoelectric Therapy System

Recall date
April 27, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1404-2022
FDA classification
Class II
Brand / firm
Xstrahl Limited
Sold / distributed
US Distribution FL, CA, KY

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

X80 RADiant Photoelectric Therapy System

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