DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
FDA Recall Z-0457-2016 · Posted 2015-12-22
Recalling FirmBC Group International Inc
Recall StatusTerminated
Product CodeDRL
Date Initiated2015-10-28
Date Terminated2017-02-15
Product Quantity5 units
Reason for Recall
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Firm 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 devices and return them.
Root Cause
Employee error
Distribution Pattern
US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.