Z-0457-2016 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2015
- Initiation Date
- October 28, 2015
- Termination Date
- February 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Reason for Recall
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Distribution Pattern
US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
Code Information
SN: 73962222, 73962223, 73962224, 73962225, and 73962226