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.
device · product 1 of 2
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Code information
Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.
Distribution pattern
Worldwide Distribution -- USA (nationwide) Distribution
device · product 2 of 2
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Code information
Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.
Distribution pattern
Worldwide Distribution -- USA (nationwide) Distribution
