FDA Device recall Z-0457-2016
DA-2006P - Defibrillator / Pacer Analyzer
- FDA Device
- Class III
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class III recall of DA-2006P - Defibrillator / Pacer Analyzer by Bc Group International, citing device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0457-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-10-28 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bc Group International |
| Distribution | US |
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.
Identifiers
| code_info | SN: 73962222, 73962223, 73962224, 73962225, and 73962226 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0457-2016%22
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