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.
Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
Code information
DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165
Distribution pattern
Worldwide distribution - US Nationwide distribution in the states of MI, KS, OH, VA, DC, FL, PA, OK, MN, AZ and the countries of South Korea, Netherlands, Poland, China.
