All Recalls

95,064 total recalls in our database

It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.

Jun 7, 2017 Other Medical Devices Nationwide View Details →

The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.

Sep 25, 2018 Implants & Prosthetics Nationwide View Details →