Terminated

Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.

FDA Recall Z-1745-2014 · Posted 2014-06-22

Recalling FirmPhilips Medical Systems (Cleveland) Inc

Recall StatusTerminated

Product CodeJAK

Date Initiated2013-12-19

Date Terminated2015-08-25

Product Quantity454 Units

Reason for Recall

During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio frequency emissions. Specifically, at the 48MHZ frequency, the testing indicated the Brilliance CT Big Bore was 3.5dB uV/meter higher than the applicable IEC 60601-1-2 standard specification.

Firm Action

Philips Medical System sent an Urgent Medical Device Corrections letters dated December 10, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a field service Engineer will visit the facility to perform an Electro-Magnetic Interference (EMI) noise reduction up0date on each system. For information or support concerning contact your local Philips representative: For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, OptionS: Enter site ID or follow prompts).

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US (nationwide) in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV. and countries of Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, France, French Polynesia, Gabon, Germany, India, Indonesia, Israel, Italy, Jordan, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Oman, Palestine, Philippines, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Ukraine & United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033357ACQSIM-MULTISLICE-CT, MODEL 453567042271Philips Medical Systems (Cleveland), Inc. · 2004-01-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.