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FDAOctober 28, 2015device

DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.

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

The hazard

Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

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

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