Neural Signal Amplifier recall
Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System…
Why was Neural Signal Amplifier recalled?
Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts.
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?
Part Number 4208: Serial Numbers 0014 and 0016 Only Part Number 5703: All Serial Numbers Part Number 5748: All Serial Numbers Part Number 5747: All Serial Numbers
- Product
- Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System…
- Recalling firm
- Blackrock Microsystems, LLC
- Quantity
- 81 total amplifiers
- Distribution
- Worldwide Distribution - US Nationwide and Canada,
- Recall date
- September 14, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)