Recall Z-0457-2016 ยท DRL Tester, Defibrillator
BC Group International Inc
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
| Date | Dec 22, 2015 (initiated Oct 28, 2015) |
| Status | Terminated |
| Reason | Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms. |
| Root cause | Employee error |
| Action | The recalling firm issued return authorization numbers to the two customers who submitted complaints regarding the malfunctioning device. The customers sent back the units and the recalling firm replaced their devices with new units. On 10/29/2015, the recalling firm contacted their third customer by phone and informed them that the three devices they had in their possession were miswired which would cause the inverted ECG waveform. The recalling firm issued a return authorization number to their customer for the three devices. The recalling firm told their customer they would repair the devic |
| Quantity | 5 units |
| Distribution | US Nationwide Distribution in the states of South Carolina, Florida, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110192 | DEFIBRILLATOR ANALYZER - DA-2006P Bc Group International, Inc., Feb 8, 2011 |