FDA Devices Moderate Class II Terminated

Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Reported: November 4, 2015 Initiated: September 14, 2015 #Z-0173-2016

Product Description

Reason for Recall

The firm discovered Ring/Dot artifact due to X-ray measurement error.

Details

Recalling Firm: Philips Medical Systems (Cleveland) Inc
Units Affected: 323 units
Distribution: Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
Location: Cleveland, OH

Frequently Asked Questions

What product was recalled? ▼

Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 323 units.

Why was this product recalled? ▼

The firm discovered Ring/Dot artifact due to X-ray measurement error.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 4, 2015. Severity: Moderate. Recall number: Z-0173-2016.