FDAAugust 10, 2016device
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 in...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Terminated
Brands named
blackrock microsystemsblackrock
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDALeica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system2022-11-21
- FDALeica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system2022-11-21
- FDALeica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system2022-11-21
- FDALeica Surgical Operating Microscopes, M530 OHX, Part Number 104487372022-08-26
- FDALeica Surgical Operating Microscopes, Arveo, Part Number 104489992022-08-26
- FDALeica Surgical Operating Microscopes, ARveo 8, Part Number 104490632022-08-26
- FDALeica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 104489502022-08-26
- FDALeica Microsystems M220 F12 Microscope Systems2021-11-03
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →