DA-2006P - Defibrillator / Pacer Analyzer recall
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Why was DA-2006P - Defibrillator / Pacer Analyzer recalled?
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SN: 73962222, 73962223, 73962224, 73962225, and 73962226
- Product
- DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
- Recalling firm
- BC Group International Inc
- Quantity
- 5 units
- Distribution
- US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
- Recall date
- December 30, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)