Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Bl
FDA device recall Z-2764-2016 · posted 2016-09-08 · Terminated
Recall details
- Recalling firm
- Blackrock Microsystems, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- GWL
- Quantity affected
- 120 total cables
- Distribution
- Worldwide Distribution - US Nationwide and Canada,
- Date initiated
- 2016-08-10
- Date posted
- 2016-09-08
- Date terminated
- 2017-08-21
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM (K090957) | I2s Micro Implantable Systems, LLC | 2009-05-28 |