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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90231

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 27, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Xstrahl Limited

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

X80 RADiant Photoelectric Therapy System

Z-1404-2022
Recall number
Z-1404-2022
Initiated
April 27, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Xstrahl Limited
Quantity
7 devices; 70 treatment applicators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential compatibility issue with the systems and replacement treatment applicators.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Finished device change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential compatibility issue with the systems and replacement 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