🔍 RecallPedia

Spectrum Medical

5 recalls •

🏥 Medical Devices

• Categories: Diagnostic Equipment, Infusion Pumps

Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.

Class I - Dangerous

Medical device software marketed without FDA clearance .

Mar 19, 2025 Diagnostic Equipment View Details →

Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

Class I - Dangerous

Medical device software marketed without FDA clearance .

Mar 19, 2025 Diagnostic Equipment View Details →

Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A

Class I - Dangerous

Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.

Jan 16, 2025 Infusion Pumps Nationwide View Details →

Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00

Class I - Dangerous

The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.

Mar 13, 2023 Infusion Pumps Nationwide View Details →

Quantum Pump Console

Class I - Dangerous

Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

May 29, 2019 Infusion Pumps View Details →