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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94443

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

Open FDA event record

Event summary

Timeline bucket
April 11, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
FUJIFILM Healthcare Americas Corporation

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

FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33

Z-1898-2024
Recall number
Z-1898-2024
Initiated
April 11, 2024
Classification
Class II
Status
Ongoing
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

Code information

UDI-DI: 04540217052226 04540217057450 S/N: MP95A9F6A001, MP95A9F74002, MP95A9F74001, MP95AA983002, MP95AA985001, MP95AA985003, MP95AA985002, MP95AA988001, MP95AA993001, MP95AA996002, MP95AA996001, MP95AA997001, MP95A9F6B001, MP95A9F76001, MP95AA983001, MP95AA988002, MP95AA98A001, MP95AA993002

Distribution pattern

US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.