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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93614

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

Open FDA event record

Event summary

Timeline bucket
December 13, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
SEDECAL SA

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

Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.

Z-0781-2024
Recall number
Z-0781-2024
Initiated
December 13, 2023
Classification
Class II
Status
Ongoing
Recalling firm
SEDECAL SA
Quantity
845 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.

Code information

All serial numbers, UDI-DI 08436046002500.

Distribution pattern

Distribution was made to AL, FL, and NC. There was no military/government distribution.