Z-3132-2017 Class II Terminated
FDA device recall Z-3132-2017 was initiated by Boston Scientific Corporation on May 15, 2017 and is designated Class II. Reason for recall: The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing. The recall status is terminated (terminated July 6, 2021). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2017
- Initiation Date
- May 15, 2017
- Termination Date
- July 6, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
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.
Distribution Pattern
US Distribution to one customer in Missouri.
Code Information
Lot/Batch No. (Exp Date): SPM01975 (09/05/2044), SPM00890 (09/27/2043), SPM01616 (06/28/2044)