Philips Medical Systems (Cleveland) Inc recalls Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore O

Recalled October 23, 2013 · FDA recall Z-0013-2014 · Philips Medical Systems (Cleveland)

Hazard

There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds. · FDA Class II

Units

258

Sold at

Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR,TN, TX, UT, VA, VT and WV., and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Denmark, Egypt, France, Germany, Honduras, India, Indonesia, Italy, Kazakhstan, Latvia, Lebanon, Libyan Arab Jamahiriya, Mexico, Netherlands, Norway, Palestine, Philippines, Poland, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom and Vietnam.

Description

There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.

Product

Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories.

Manufacturer(s)

Philips Medical Systems (Cleveland) Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →