CLASS II ONGOING Device recall · Reported 27 Jul 2022 · FDA Enforcement Report
X80 RADiant Photoelectric Therapy System recalled by Xstrahl
Xstrahl is recalling X80 RADiant Photoelectric Therapy System, distributed in California, Florida, Kentucky. The recall was initiated on 27 Apr 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1404-2022
- FDA event ID
- 90231
- Recalling firm
- Xstrahl, Walsall, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Apr 2022
- FDA classified
- 19 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Apr 2022 | Recall initiated by company | |
| 19 Jul 2022 | Classified by FDA | +83 days |
| 27 Jul 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential compatibility issue with the systems and replacement treatment applicators.
Product as listed by the FDA
X80 RADiant Photoelectric Therapy System
Where it was distributed
US Distribution FL, CA, KY
Questions about this recall
Why was it recalled?
There is a potential compatibility issue with the systems and replacement treatment applicators.
Which lots are affected?
Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008
Where was it sold?
US Distribution FL, CA, KY
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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