Recall Z-2764-2016 ยท GWL Amplifier, Physiological Signal
Blackrock Microsystems, LLC
Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocard
| Date | Sep 8, 2016 (initiated Aug 10, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling False and Misleading |
| Action | Blackrock Microsystems sent an Urgent Medical Device letter dated August 12, 2016 via email. The letter identified the affected product, problem and actions to be taken. Customers were instructed not use the amplifier in application requiring a type CF applied part; perform a physical count of the inventory of amplifiers and patient cables with the part numbers listed. For questions regarding this Correction call 801-582- 5533, ext. 240. |
| Quantity | 120 total cables |
| Distribution | Worldwide Distribution - US Nationwide and Canada, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090957 | BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM I2s Micro Implantable Systems, LLC, May 28, 2009 |