Home / Recalls / Medical Devices
BC Group International Inc recalls DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or trans
Recalled December 30, 2015 · FDA recall Z-0457-2016 · BC Group International
Hazard
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms. · FDA Class III
Units
5 units
Sold at
US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
Description
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Product
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Manufacturer(s)
BC Group International Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →