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FDAOctober 14, 2013device

Philips Multi Diagnost Eleva II

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

philips medical systemsphilipsphilips medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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