Recall Z-1874-2016 · JAK System, X-Ray, Tomography, Computed

Philips Medical Systems (Cleveland) Inc

Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Date	Apr 8, 2016
Status	Terminated
Reason	The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Root cause	Software design
Action	The firm sent a Customer Information letters dated March 8, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For information or support concerning this issue, please contact your 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 or follow the prompts).
Quantity	424 Units
Distribution	Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argenti
FDA record	Open on fda.gov

510(k) clearances named in this recall

K033326

PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
Philips Medical Systems, Inc., Oct 29, 2003