Company: Philips Medical Systems, Inc.
Date of Enforcement Report 8/17/2016
Ingenuity Core Computed Tomography X-ray systems X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Recall Number Z-2371-2016
Software defect causing intermittently slow response of Host.
Philips Medical Systems, Inc., Cleveland, OH on 3/24/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally