Recall Z-1353-2016 · JAK System, X-Ray, Tomography, Computed

Philips Medical Systems (Cleveland) Inc

Brilliance iCT SP 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

Date	Feb 5, 2016
Status	Terminated
Reason	The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Root cause	Software design
Action	Philips Medical Systems sent a Customer Information dated February 5, 2016, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. To correct the issue Philips will release field change orders (FCO) 72800652 and 72800644 to install a software update on the affected systems. Customers with questions were instructed to contact their local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID o
Quantity	49 Units
Distribution	Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Aust
FDA record	Open on fda.gov

510(k) clearances named in this recall

K060937

BRILLIANCE VOLUME
Philips Medical Systems (Cleveland), Inc., Jun 5, 2006