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.
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
These labels are deterministic app interpretations, not FDA categories.
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Code information
Model Number: 11343300; UDI-DI: 04056869124575; System Serial Numbers: 1296, 10550, 10572, 10606, 10608, 11511, 20140;
Distribution pattern
Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
These labels are deterministic app interpretations, not FDA categories.
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Code information
Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 6734, 6694, 10121, 10309, 10336, 10342;
Distribution pattern
Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
These labels are deterministic app interpretations, not FDA categories.
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Code information
Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 10559;
Distribution pattern
Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
