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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85416

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

Open FDA event record

Event summary

Timeline bucket
November 04, 2019
Product types
Device
Classifications
Class II
Statuses
Completed
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

Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.

Z-2591-2020
Recall number
Z-2591-2020
Initiated
November 04, 2019
Classification
Class II
Status
Completed
Recalling firm
Shimadzu Medical Systems
Quantity
3 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The DAP meters were found to be outside of tolerance.

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

The DAP meters were found to be outside of tolerance.

Code information

Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.

Distribution pattern

US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.