FDA-Device2015-03-04Class II
Philips Multi Diagnost Eleva with FlatDetector
Philips Medical Systems, Inc.
Hazard
The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.
Sold states
Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.
Affected count
238
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips Multi Diagnost Eleva with FlatDetector
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1045-2015Don't want to check this manually?
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