Spectrum Medical recalls
4 official recalls and safety alerts involving Spectrum Medical since 2024-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Spectrum Medical or the relevant agency.
- 2026-10-07
USSPECTRUM MEDICAL SRL recalls Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W…
Due to blood-to-glycol leak in the heat exchanger.
FDA · DeviceSPECTRUM MEDICAL SRLUS Nationwide distribution in the states of AL, CA, FL, KS MA, MD, MI, MO, NC,…Official notice →- 2025-05-07
- US
Spectrum Medical Ltd. recalls Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product…
Medical device software marketed without FDA clearance .
FDA · DeviceSpectrum Medical Ltd.California, Florida, Illinois, Arkansas, Georgia, Wisconsin, Arizona,…Official notice → - 2025-03-19
- US
Spectrum Medical Inc recalls Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass,…
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
FDA · DeviceSpectrum Medical IncUS Nationwide distribution including in the states of Alabama, Arizona,…Official notice → - 2024-10-30
- US
Spectrum Medical Ltd. recalls Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing.…
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
FDA · DeviceSpectrum Medical Ltd.US Nationwide distribution including in the states of Alabama, California,…Official notice →