Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report: 10/7/2014
Class lI:

PRODUCT

The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Recall Number Z-2711-2014

REASON
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc, cleveland, OH on 9/11/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
79

DISTRIBUTION
Nationwide and Internationally

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