Recall Z-3132-2017 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Boston Scientific Corporation
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 monitorin
| Date | May 15, 2017 |
| Status | Terminated |
| Reason | The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing. |
| Root cause | Unknown/Undetermined by firm |
| Action | Boston Scientific sent an Important Medical Device Information letter dated May 30, 2017, to their affected consignee. On May 15, 2017, Boston Scientific visited the consignee and exchanged the affected device for a device that met specifications. The letter requested a response form be completed and returned. For questions customers should call 763-494-1133. |
| Quantity | 3 |
| Distribution | US Distribution to one customer in Missouri. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170204 | FFR Link, FFR Signal Processing Module Boston Scientific Corporation, Mar 24, 2017 |