Every recall we track for Spectrum Medical Ltd. — 4 in all — plus the complaints and injury reports the public filed about them.
Quantum Informatics recalls VISION/LIVE VUE patient monitoring software due to lack of FDA clearance. This software-only device may not be safe for use in operating rooms without regulatory approval.
Spectrum Medical Ltd. recalls Quantum Informatics VIPER patient monitors with unapproved medical software. These software-only devices lack FDA clearance for patient safety monitoring, potentially failing to detect critical health issues during surgery.
Spectrum Medical recalls Quantum Perfusion Systems for CPB roller pumps due to left bobbin lock failure. Affected units have specific serial numbers and catalog codes. Contact for remedy.
Spectrum Medical recalls Quantum Pump Consoles with software version 6.2.1.9 due to potential unexpected shutdowns while in use. Affected units have specific serial numbers listed in the recall notice.