Company: Philips Medical Systems, Inc.
Date of Enforcement Report 8/17/2016
Ingenuity Core Model No. 728323; To produce cross-sectional images of the body.
Recall Number Z-2384-2016
Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
Philips Medical Systems, Inc., Cleveland, OH on 4/29/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally