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
Reported: July 25, 2012 Initiated: July 2, 2012 #Z-2035-2012
Product Description
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
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.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 524
- Distribution
- 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.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 524.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2012. Severity: Moderate. Recall number: Z-2035-2012.
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