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.
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.
Monitor has either not turned on or has lost image during clinical use.
Code information
Serial number range: 3000038-3004884, 3100035-3100058, 3100065-3100145.
Distribution pattern
Worldwide Distribution - US Distribution to the states of : FL and NC., and to the countries of : Ecuador, Costa Rica, Brazil, Nicaragua, Venezuela, Peru, Colombia, Dominican Republic, and South Korea.