FDA-Device2015-12-30Class III
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
BC Group International Inc
Hazard
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Sold states
US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
Affected count
5 units
Manufactured in
3081 Elm Point Industrial Dr, N/A, Saint Charles, MO, United States
Products
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0457-2016Don't want to check this manually?
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