Date Initiated by Firm |
October 28, 2015 |
Date Posted |
December 22, 2015 |
Recall Status1 |
Terminated 3 on February 15, 2017 |
Recall Number |
Z-0457-2016 |
Recall Event ID |
72619 |
510(K)Number |
K110192
|
Product Classification |
Tester, defibrillator - Product Code DRL
|
Product |
DA-2006P - Defibrillator / Pacer Analyzer;
Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
|
Code Information |
SN: 73962222, 73962223, 73962224, 73962225, and 73962226 |
Recalling Firm/ Manufacturer |
BC Group International Inc 3081 Elm Point Industrial Dr Saint Charles MO 63301-4333
|
For Additional Information Contact |
Melvin L. Roche, Jr. 314-638-3800
|
Manufacturer Reason for Recall |
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DRL and Original Applicant = BC GROUP INTERNATIONAL, INC
|