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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73468

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

Open FDA event record

Event summary

Timeline bucket
February 01, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Laserex Systems 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

Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .

Z-1270-2016
Recall number
Z-1270-2016
Initiated
February 01, 2016
Classification
Class II
Status
Terminated
Recalling firm
Laserex Systems Inc.
Quantity
72 units plus 2 spare units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design error

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 Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.

Code information

Model Number : 3143270

Distribution pattern

Worldwide Distribution - US Distribution