Z-0457-2016 Class III Terminated
FDA device recall Z-0457-2016 was initiated by BC Group International Inc on October 28, 2015 and is designated Class III. Reason for recall: Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms. The recall status is terminated (terminated February 15, 2017). Affected quantity: 5 units.
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