Z-0457-2016Class III

DA-2006P - Defibrillator / Pacer Analyzer

Name: Z-0457-2016 DA-2006P - Defibrillator / Pacer Analyzer
Creator: BC Group International Inc
Published: 2015-10-28
License: https://open.fda.gov/license/

BC Group International Inc / initiated 2015-10-28 / Terminated / root cause: manufacturing process

FDA source

BC Group International Inc began a recall of DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker on 2015-10-28. FDA classified it as Class III and gives the reason as "Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0457-2016
Classification: Class III
Status: Terminated
Initiated: 2015-10-28
Posted: 2015-12-22
Terminated: 2017-02-15
Recalling firm: BC Group International Inc
Product: DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Product code: DRL Tester, Defibrillator
Reason for recall: Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Root cause tag: manufacturing process
FDA 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 devices and return them.
Quantity in commerce: 5 units
Distribution: US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
Product codes and lots: SN: 73962222, 73962223, 73962224, 73962225, and 73962226

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0457-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0457-2016	Class III	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-21

Product code DRL

K110192Class IIDefibrillator Analyzer - Da-2006PBc Group International, Inc. / cleared 2011-02-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)