BC Group International Inc recalls DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcut…
- Recall date
- October 28, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0457-2016
- FDA classification
- Class III
- Brand / firm
- BC Group International Inc
- Sold / distributed
- US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
Why it was recalled
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
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