Device Recall Vertical Brake Hubs of the Computed Tomography XRay Systems

Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brilliance 16, M/Ns 5001-6180, 50002-50139 ; Brilliance 16P, M/Ns 6007-6163, 60001-60029 ; Brilliance 40, M/Ns 9009-9272, 29001-29153, 90028-92034; Brilliance 64, M/Ns 9501-10300, 95003-95697; Brilliance Big Bore, M/Ns 7001-7520; Brilliance iCT, M/Ns 100003-100169 & Brilliance iCT SP, M/Ns 200004-200034.

Radiology Devices

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Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO,CT, DC, DE, FL, GA, HI, IA, ID, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY, and the countries of Afghanistan; Algeria; Angola; Argentina; Australia; Austria; Azerbaijan; Bahamas; Bahrain; Bangladesh; Belgium; Bolivia; Bosnia & Herzegovina; Brazil; Brunei Darussalam; Bulgaria; Cambodia; Canada; Chile; China; Columbia; Costa Rica; Cote d'Ivoire; Croatia; Cyprus; Czech Republic; Denmark; Dominican Republic; Ecuador; Egypt; El Salvador; England; Equatorial Guinea; Finland; France; French Polynesia; Germany; Greece; Hong Kong; Hungary; Iceland; India; Indonesia; Iran; Iraq; Ireland; Israel; Italy; Jamaica; Japan; Jordan; Kazakhstan; Kenya; Kuwait; Latvia; Lebanon; Libyan Arab Jamahiriya; Lithuania; Luxembourg; Madagascar; Malaysia; Malta; Martinique; Mexico; Monaco; Mongolia; Morocco; Mozambique; Namibia; Nepal; Netherlands; Netherlands; Antilles; New Zealand; Nicaragua; Nigeria; Norway; Oman; Pakistan; Panama; Paraguay; Peru; Philippines; Poland; Portugal; Romania; Russia; Saudi Arabia; Serbia & Montenegro; Singapore; Slovakia; Slovenia; South Africa; South Korea; Spain; Sweden; Switzerland; Syrian Arab Republic; Taiwan; Tanzania; Thailand; Tunisia; Turkey; Ukraine; Unidentified KM; United Arab Emirates; United Kingdom; Uzbekistan; Venezuela; Viet am & Yemen.

Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brilliance 16, M/Ns 5001-6180, 50002-50139 ; Brilliance 16P, M/Ns 6007-6163, 60001-60029 ; Brilliance 40, M/Ns 9009-9272, 29001-29153, 90028-92034; Brilliance 64, M/Ns 9501-10300, 95003-95697; Brilliance Big Bore, M/Ns 7001-7520; Brilliance iCT, M/Ns 100003-100169 & Brilliance iCT SP, M/Ns 200004-200034. || The Brilliance Computed Tomography X-Ray Systems 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.