Recall Z-0457-2016— BC Group International Inc
Class III · Terminated
Class III FDA medical device recall by BC Group International Inc, initiated 2015-10-28, terminated 2017-02-15. It names one FDA 510(k) clearance: K110192. Product: DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.. Reason: Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms..
- Recalling firm
- BC Group International Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-10-28
- Terminated
- 2017-02-15
- Firm location
- Saint Charles, MO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Reason for recall
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Data sourced from openFDA. This site is unofficial and independent of the FDA.