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U.S. Department of Health and Human Services

Class 2 Device Recall Vertical Brake Hubs of the Computed Tomography XRay Systems

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 Class 2 Device Recall Vertical Brake Hubs of the Computed Tomography XRay Systemssee related information
Date Initiated by FirmDecember 10, 2010
Date PostedMarch 16, 2011
Recall Status1 Terminated 3 on August 21, 2013
Recall NumberZ-1669-2011
Recall Event ID 57690
510(K)NumberK012009 K033326 K033357 K060937 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductVertical 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7000
Manufacturer Reason
for Recall		Philips Medical Systems has decided to recall the patient support vertical brake hub in all its Brilliance systems due to the collapse in the vertical direction. The short key connecting the vertical brake hub to the motor shaft can disengage due to the lack of thread locker on set screws.
FDA Determined
Cause 2		Other
ActionPhilips Medical Systems (Cleveland) Inc sent Field Safety Notice to all affected customers on December 10, 2010. The Safety Notices identified the product, the problem, and the action to be taken by the customer. Customers were instructed to monitor their units and if the vertical brake hub malfunctioned to immediately contact the recalling firm. The letter also stated that a Field Service Engineer would visit to perform a brake hub rework on the units. For further information or support customers were 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 or follow the prompt(s). For questions regarding this recall call 440-483-7672.
Quantity in Commerce5700 units/vertical brake hubs
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPS
510(K)s with Product Code = KPS
510(K)s with Product Code = KPS
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