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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75833

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

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Event summary

Timeline bucket
November 20, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Shimadzu Medical Systems

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

Shimadzu X-ray TV System, Catalog No. SONIALVISION G4

Z-0917-2017
Recall number
Z-0917-2017
Initiated
November 20, 2016
Classification
Class II
Status
Terminated
Recalling firm
Shimadzu Medical Systems
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.

Code information

Serial No. 41C351641002 41C351643001 41C351641003 41C351641001 41C351646001 41C351646002 41C351647001 41C35164A001 41C35164B001 41C35164C001 41C351651001 41C351651002 41C351653003 41C351653002 41C351653004 41C351653005 41C351654002 41C351655001 41C351655002 41C351655003 41C351656001 41C351659001 41C35165A001 41C35165A002 41C35165A003 41C35165B001 41C35165B002 41C351661001 41C351661002 41C351662001 41C351663001 41C351663002 41C351664001 41C351664002 41C351664004 41C351664005 41C351665001 41C351665003 41C351665002

Distribution pattern

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