September 20, 2024

Sep

FDA Recall: Software Correction to Mitigate Risk of Problems that Pose a Risk of Hemodynamic Instability

September 20, 2024Allison PateNews

Company: Datascope Corp. Date of Enforcement Report: 9/20/2024 Class I PRODUCT CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Recall Number: Z-3135-2024 REASON: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of...

Sep

FDA Recall: Software Correction for Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices

September 20, 2024Allison PateNews

Company: Datascope Corp. Date of Enforcement Report: 9/20/2024 Class I PRODUCT CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Recall Number: Z-3134-2024 REASON: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of...

FDA Recall: Software Correction to Mitigate Risk of Problems that Pose a Risk of Hemodynamic Instability

FDA Recall: Software Correction for Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices

Upcoming Public Courses

Corporate Office

Day

FDA Recall: Software Correction to Mitigate Risk of Problems that Pose a Risk of Hemodynamic Instability

FDA Recall: Software Correction for Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices

Upcoming Public Courses

Corporate Office