Class III — BC Group International Inc
| Recalling firm | BC Group International, Inc. |
|---|---|
| Registered facility | BC GROUP INTERNATIONAL, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms. |
| Product | DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker. |
| Quantity | 5 units |
| Distribution | US Nationwide Distribution in the states of South Carolina, Florida, and Canada. |
| Initiated | 2015-10-28 |
| Classified | 2015-12-21 |
| Terminated | 2017-02-15 |
| Recall number | Z-0457-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — BC Group International Inc (Z-0457-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72619/
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