PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 20, 2017 Initiated: May 15, 2017 #Z-3132-2017

Product Description

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.

Details

Units Affected
3
Distribution
US Distribution to one customer in Missouri.
Location
Marlborough, MA

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Boston Scientific Corporation. Units affected: 3.
Why was this product recalled? ▼
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 20, 2017. Severity: Moderate. Recall number: Z-3132-2017.

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