FDA-Device2012-09-26Class II
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
Philips Medical Systems (Cleveland) Inc
Hazard
On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Sold states
Worldwide distribution, Nationwide (US) including the states AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, and VA and the countries of Albania, Argentina, Australia, Belgium, Brazil, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Italy, Jordan, Lebanon, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Turkey, Uganda, and Venezuela.
Affected count
328 units
Manufactured in
595 Miner Road, Cleveland, OH, United States
Products
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2386-2012Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief