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 1
The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. Philips has disabled this feature at all sites evaluating 4.0 Beta 2 software. Philips will issue a software up
