Company: Toshiba American Medical Systems Date of Enforcement Report 9/20/2017 Class lI: PRODUCT Toshiba Medical Radrex – i Digital Radiography X-ray systemRadrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of...Read More

Company:Mako Surgical Corporation.Date of Enforcement Report 9/20/2017 ClasslI: PRODUCT Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. Recall Number Z-3130-2017 REASON Software discrepancy of not showing...Read More

Company:Mako Surgical Corporation.Date of Enforcement Report 9/20/2017 ClasslI: PRODUCT Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. Recall Number Z-3131-2017 REASON Software discrepancy of not showing all...Read More

Company:Boston Scientific Corporation.Date of Enforcement Report 9/20/2017 ClasslI: 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...Read More

Company:Baxter Healthcare CorpDate of Enforcement Report 9/20/2017 ClasslI: PRODUCT Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 Recall Number Z-3133-2017 REASON The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette....Read More