Exact FDA event identifier

Event 87593

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

Open FDA event record

Event summary

Timeline bucket: March 16, 2021
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Boston Scientific Corporation

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

EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430

Z-1492-2021

Recall number: Z-1492-2021
Initiated: March 16, 2021
Classification: Class III
Status: Terminated
Recalling firm: Boston Scientific Corporation
Quantity: 3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

May have been programmed with a less than optimal brightness setting resulting in a darker than desired image

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

May have been programmed with a less than optimal brightness setting resulting in a darker than desired image

Code information

Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901

Distribution pattern

US Nationwide distribution in the states of CA, FL, NJ.