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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98076

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

Open FDA event record

Event summary

Timeline bucket
December 05, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Beaver-Visitec International, Inc.

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

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

Z-1008-2026
Recall number
Z-1008-2026
Initiated
December 05, 2025
Classification
Class II
Status
Ongoing
Quantity
5 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Manufacturing deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).

Code information

Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.

Distribution pattern

US Nationwide distribution in the states of FL, MI, OK, TX, WI.