Facility

SPECTRUM MEDICAL SRL

4 recall(s) on record — most severe on record: Class I.

Key facts

4recalls · worst Class I

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3016746283
Establishment type	Manufacture Medical Device
Location	Via di Mezzo, 23 Mirandola Modena, IT 41037
Registration status	Active · expires 2026
Parent company	Spectrum Medical SRL (owner-operator 10069754)
Brand names	QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP20; QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP20 WITH INTEGRATED SENSORS

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Product code KFM (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4360

Recalls & enforcement

Class IIOngoing2025-03-19
Medical device software marketed without FDA clearance .
Class IIOngoing2025-01-16
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Class IICompleted2023-03-13
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Class ITerminated2019-05-29
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

FDA inspections (1)

NAI2023-05-11
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Spectrum Medical SRL

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SPECTRUM MEDICAL SRL (FEI 3016746283) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3016746283-spectrum-medical-srl/

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