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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78973

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

Open FDA event record

Event summary

Timeline bucket
April 25, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medistim Asa

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

MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

Z-0719-2018
Recall number
Z-0719-2018
Initiated
April 25, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medistim Asa
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.

Code information

UDI: 7070554101198 Serial#: 1170 and 1294

Distribution pattern

Distributed to New York.