FDA-Device2015-03-04Class II
Philips Multi Diagnost Eleva II
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 II
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1044-2015Don't want to check this manually?
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