Terminated

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.

FDA Recall Z-1669-2011 · Posted 2011-03-16

Recalling FirmPhilips Medical Systems (Cleveland) Inc

Recall StatusTerminated

Product CodeKPS

Date Initiated2010-12-10

Date Terminated2013-08-21

Product Quantity5700 units/vertical brake hubs

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.

Firm Action

Philips 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060937BRILLIANCE VOLUMEPhilips Medical Systems (Cleveland), Inc. · 2006-06-05 K033357ACQSIM-MULTISLICE-CT, MODEL 453567042271Philips Medical Systems (Cleveland), Inc. · 2004-01-09 K033326PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEMPhilips Medical Systems, Inc. · 2003-10-29 K012009MX8000 IDT CT SYSTEMMarconi Medical Systems, Inc. · 2001-09-13

Official Source

View FDA Recall →

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