Philips Medical Systems, Inc. recalls Philips Multi Diagnost Eleva with FlatDetector

Recall date

October 14, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1045-2015

FDA classification

Class II

Brand / firm

Philips Medical Systems, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Multi Diagnost Eleva with FlatDetector