DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
This recall has been terminated (originally issued December 22, 2015).
- Company
- Bc Group International Inc
- Recall Initiated
- October 28, 2015
- Posted
- December 22, 2015
- Terminated
- February 15, 2017
- Recall Number
- Z-0457-2016
- Quantity
- 5 units
- Firm Location
- Saint Charles, MO
- Official Source
- View on FDA website ↗
Reason for Recall
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Distribution
US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
Lot / Code Info
SN: 73962222, 73962223, 73962224, 73962225, and 73962226
Root Cause
Employee error
Action Taken
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 devices and return them.