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Philips Medical Systems, Inc. recalls Philips Multi Diagnost Eleva II
Recalled March 4, 2015 · FDA recall Z-1044-2015 · Philips Medical Systems
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. · FDA Class II
Units
238
Sold at
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.
Description
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.
Product
Philips Multi Diagnost Eleva II
Manufacturer(s)
Philips Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →