← Every firm
Spectrum Medical Ltd. FDA Recalls
3 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Class IIMar 19, 2025Medical device software marketed without FDA clearance . |
| Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia DClass IIMar 19, 2025Medical device software marketed without FDA clearance . |
| Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial cClass IIMar 13, 2023The ratchet and pawl had an out of tolerance geometry which |