FDA Enforcement
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
Recall: Z-3132-2017
·
Reported September 20, 2017
Enforcement
- Recall Number
- Z-3132-2017
- Event ID
- 77444
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- September 20, 2017
- Initiation Date
- May 15, 2017
- Classification Date
- September 13, 2017
- Termination Date
- July 6, 2021
- Address
- 100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States
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
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Code Info
Lot/Batch No. (Exp Date): SPM01975 (09/05/2044), SPM00890 (09/27/2043), SPM01616 (06/28/2044)
Distribution
US Distribution to one customer in Missouri.
Quantity
3