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U.S. Department of Health and Human Services

Class 3 Device Recall Defibrillator / Pacer Analyzer

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 Class 3 Device Recall Defibrillator / Pacer Analyzersee related information
Date Initiated by FirmOctober 28, 2015
Date PostedDecember 22, 2015
Recall Status1 Terminated 3 on February 15, 2017
Recall NumberZ-0457-2016
Recall Event ID 72619
510(K)NumberK110192 
Product Classification Tester, defibrillator - Product Code DRL
ProductDA-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 ContactMelvin 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
ActionThe 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 Commerce5 units
DistributionUS Nationwide Distribution in the states of South Carolina, Florida, and Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DRL
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