Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93217

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

Open FDA event record

Event summary

Timeline bucket
September 14, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Olympus Corporation of the Americas

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

EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation

Z-0056-2025
Recall number
Z-0056-2025
Initiated
September 14, 2023
Classification
Class II
Status
Ongoing
Quantity
45 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.

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

Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.

Code information

UDI-DI: 04953170298622; Serial Numbers: 7384484 7384422 7384487 7384478 7384479 7384442 7384441 7384485 7384451 7384455 7384481 7384470 7384424 7384423 7384489 7384531 7384516 7384492 7384512 7384543 7384483 7384624 7384623 7384497 7384495 7384494 7384533 7384622 7384660 7384654 7384656 7384647 7384658 7384675 7384655 7384704 7384709 7384687 7384706 7384661 7384662 7384703 7384670 7384679 7384678

Distribution pattern

US Nationwide distribution.