Cl II Philips Brilliance 16

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 8/17/2016
Class lI:

PRODUCT

Brilliance 16 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-2369-2016

REASON
Software defect causing intermittently slow response of Host.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 3/24/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
203 units

DISTRIBUTION
Nationwide and Internationally

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