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BC Biomedical Defibrillator Analyzer Variable Load

BC GROUP INTERNATIONAL, INC. · Model DA-2006-VL · UDI-DI 00863313000323

DRL
1
510(k) clearances
5
Adverse events
1
Recalls
4
Facilities

Description

Defibrillator Analyzer Variable Load, for use with DA-2006 and DA-2006P models.

Recalls

DateFirmReason
2015-10-28BC Group International IncDevice is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.