BC Group International DA-2006P - Defibrillator / Pacer Analyzer recall — FDA Z-0457-2016
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Overview of recall records associated with BC Group International Inc., including dates, categories and classifications where available.
Classification mix: Class III: 1.
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
This page summarizes recall records in which the official source identifies BC Group International Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.