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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94193

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

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Event summary

Timeline bucket
March 09, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Noah Medical

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

Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Z-1734-2024
Recall number
Z-1734-2024
Initiated
March 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Noah Medical
Quantity
17 wired controllers

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.

Code information

Model Number: GAL-001 Wired Controller Model Number: GAL-019 UDI-DI code: 00850048825048 (additional information pending) Serial Numbers: GWC-1529 GWC-1538 GWC-1541 GWC-1576 GWC-1579 GWC-1560 GWC-1566 GWC-1586 GWC-1590 GWC-1581 GWC-1589 GWC-1552 GWC-1572 GWC-1547 GWC-1571 GWC-1564 GWC-1537

Distribution pattern

U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.