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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88545

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

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Event summary

Timeline bucket
August 27, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
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

Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system

Z-0389-2022
Recall number
Z-0389-2022
Initiated
August 27, 2021
Classification
Class II
Status
Terminated
Recalling firm
Xstrahl Limited
Quantity
120 applicators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Base plate may detach from the main body of the treatment applicator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Base plate may detach from the main body of the treatment applicator.

Code information

GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506

Distribution pattern

US and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA, CYPRUS, DENMARK, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KAZAKHSTAN, LATVIA, MALTA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, ROMANIA, RUSSIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UK, UKRAINE