Reported Dec 30, 2015 · Terminated
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or…
BC Group International Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BC Group International Inc · 3081 Elm Point Industrial Dr · Saint Charles, MO · 63301-4333
Is this the product you have?
- DA-2006P - Defibrillator / Pacer Analyzer
- Product UsageIntended to measure the output of a defibrillator or transcutaneous pacemaker
- Lot codes and dates
- SN
73962222739622237396222473962225and 73962226
- SN
- Amount recalled
- 5 units
Where it was sold
Why it was recalled
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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