Brand
Spectrum Medical Ltd.
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Spectrum Medical Ltd. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-05-07FDA-DeviceClass IIBrand 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 info
Medical device software marketed without FDA clearance .
- 2025-05-07FDA-DeviceClass IIBrand 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 act
Medical device software marketed without FDA clearance .
- 2024-10-30FDA-DeviceClass IIQuantum 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
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
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