Spectrum Medical SRL
4 recall(s) on record — most severe on record: Class I.
Recalls by year
- Recalls (4)
Registered facilities (1)
- SPECTRUM MEDICAL SRL FEI 3016746283 · IT
Recalls & enforcement
- Class IIOngoing2025-03-19Medical device software marketed without FDA clearance .
- Class IIOngoing2025-01-16Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
- Class IICompleted2023-03-13The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
- Class ITerminated2019-05-29Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Spectrum Medical SRL — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10069754-spectrum-medical-srl/
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