Brilliance 64 & Ingenuity Computed Tomograpy Cl ll

Company:Philips Medical Systems Inc.
Date of Enforcement Report 3/20/2013
Class ll:

PRODUCT

Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body 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-0950-2013

REASON
This field change order is being released to update software and customer release notes to the affected installed base.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems Inc., Cleveland, OH on 2/15/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
42 Units

DISTRIBUTION
Nationwide and Internationally

___________________________________

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.