Device 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
Z-3132-2017
Product summary
- Event
- Event 77444
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-3132-2017
Official wording
Reason: The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Code information: Lot/Batch No. (Exp Date): SPM01975 (09/05/2044), SPM00890 (09/27/2043), SPM01616 (06/28/2044)
Distribution pattern: US Distribution to one customer in Missouri.
Derived failure modes
-
Unknown
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.