Reported Jul 27, 2022 · Ongoing

X80 RADiant Photoelectric Therapy System

Xstrahl Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Xstrahl Limited · Unit 2 · Walsall, N/A · N/A

Is this the product you have?

  • X80 RADiant Photoelectric Therapy System
Lot codes and dates
  • Model NumberX80 RADiant Photoelectric Therapy System
  • Lot Codes
    • GM0549
    • GM0567 GM0568
    • GM0569
    • GM0570
    • GM0571 and GM0577
  • UDI/DI5060494200008
Amount recalled
7 devices; 70 treatment applicators

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.