Z-2764-2016Class II

Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons

Name: Z-2764-2016 Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons
Creator: Blackrock Microsystems, LLC
Published: 2016-08-10
License: https://open.fda.gov/license/

Blackrock Microsystems / initiated 2016-08-10 / Terminated / root cause: labeling and UDI

FDA source

Blackrock Microsystems, LLC began a recall of Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal... on 2016-08-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2764-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-10
Posted: 2016-09-08
Terminated: 2017-08-21
Recalling firm: Blackrock Microsystems
Product: 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), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)
Product code: GWL Amplifier, Physiological Signal
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 120 total cables
Distribution: Worldwide Distribution - US Nationwide and Canada,
Product codes and lots: Part Number 4460: All Serial Numbers Part Number 6735: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2764-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2763-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2764-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code GWL

K090957Class IIBlackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC / cleared 2009-05-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)