FDA recall Z-3132-2017

Product

FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable

Reason for recall

The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.

Distribution

US Distribution to one customer in Missouri.

Key facts

Status

Terminated

Initiation date

2017-05-15

Report date

2017-09-20

Termination date

2021-07-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3132-2017