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Spectrum Medical Recalls
5 recalls on record · September 4, 2019 to May 7, 2025 · Medical Devices
Recalls by year
19
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 7, 2025Medical DevicesFDA
Spectrum Medical Ltd. recalls Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia D
Hazard: Medical device software marketed without FDA clearance .
May 7, 2025Medical DevicesFDA
Spectrum Medical Ltd. recalls Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or
Hazard: Medical device software marketed without FDA clearance .
March 19, 2025Medical DevicesFDA
Spectrum Medical Inc recalls Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulm
Hazard: Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
October 30, 2024Medical DevicesFDA
Spectrum Medical Ltd. recalls Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial c
Hazard: The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
September 4, 2019Medical DevicesFDA
Spectrum Medical Ltd. recalls Quantum Pump Console
Hazard: Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.