BC Group International Inc: Medical Device Recall in 2015 - (Recall #: Z-0457-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.

Product Classification:

Class III

Date Initiated: October 28, 2015

Date Posted: December 30, 2015

Recall Number: Z-0457-2016

Event ID: 72619

Reason for Recall:

Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.

Status: Terminated

Product Quantity: 5 units

Code Information:

SN: 73962222, 73962223, 73962224, 73962225, and 73962226

Distribution Pattern:

US Nationwide Distribution in the states of South Carolina, Florida, and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated