Brilliance iCT and Brilliance iCT SP These 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. May include signal analysis and display equipment, patient and equipment supports, components and accessories
Reported: February 5, 2014 Initiated: July 16, 2013 #Z-0831-2014
Product Description
Brilliance iCT and Brilliance iCT SP These 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. May include signal analysis and display equipment, patient and equipment supports, components and accessories
Reason for Recall
An artifact that resembles thrombus may appear on the image.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 506
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the states AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SC, TX, VT, WA, and WV., and the countries of Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uzbekistan.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Brilliance iCT and Brilliance iCT SP These 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. May include signal analysis and display equipment, patient and equipment supports, components and accessories. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 506.
Why was this product recalled? ▼
An artifact that resembles thrombus may appear on the image.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2014. Severity: Moderate. Recall number: Z-0831-2014.
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