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Terminated

Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography 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

FDA Recall Z-2035-2012 · Posted 2012-07-19

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2012-07-02
Date Terminated2013-12-24
Product Quantity524

Reason for Recall

Philips Healthcare was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their Brilliant CT scanner have been found to be defective and the bolt heads may break off.

Firm Action

Philips sent a Urgent Medical Device Correction letter dated June 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will visit each site to inspect and correct the issue, and Philips will be tracking the progressof the correction. For further information, Customers were asked to contact their local Philips representative or Philips Healthcare Office. North American and Canadian consignees should contact the Philips Customer Care Solutions Center at 1-800-722-9377

Root Cause

Process control

Distribution Pattern

Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, MJ, NM, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, VT, and WI. and the countries of Canada, Argentina, Australia, Austria, Azerbaijan, Brazil, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Iceland, India, Indonesia, Iraq, Italy, Jordan, Kazakhstan, Kazakhstan, Libyan Arab Jamahiriya, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Palestine, Peru, Philipines, Poland, Portugal, Russia, Russia Fed, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

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

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