# SPECTRUM MEDICAL SRL · 89-08 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For SPECTRUM MEDICAL SRL · 89-08 · ITALY, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is ITALY; product is Quantum Workstation 12 Elite and Quantum Workstation Elite | Charlotte Frame Configuration (QPF5-CHARLOTTE) | Quantum Ventilation Module Lite | Quantum Pureflow Centrifugal Pumps (Centrifugal Blood Pump CP20; Centrifugal Blood Pump CP22; Centrifugal Blood Pump CP22 with Integrated Sensors; Quantum Centrifuge Drive CP 22) | Melbourne Transport Frame (QPF7-MELBOURNE); product code is 74 D - - RY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 74 D - - TQ Console, Heart-Lung Machine, Cardiopulmonary Bypass | 74 D - - TX Gas Control Unit, Cardiopulmonary Bypass | 74 K - - FM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 74 K - - RI Accessory Equipment, Cardiopulmonary Bypass; date published is 05/19/2026; address is Via Di Mezzo 23 , Mirandola, Modena ITALY, verified against its source on 2026-09-16.

- **Firm:** SPECTRUM MEDICAL SRL _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** ITALY _(verified: appears in the quote below)_
- **Address:** Via Di Mezzo 23 , Mirandola, Modena ITALY _(verified: appears in the quote below)_
- **Date published:** 05/19/2026 _(verified: appears in the quote below)_
- **Product code:** 74 D - - RY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 74 D - - TQ Console, Heart-Lung Machine, Cardiopulmonary Bypass | 74 D - - TX Gas Control Unit, Cardiopulmonary Bypass | 74 K - - FM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 74 K - - RI Accessory Equipment, Cardiopulmonary Bypass _(verified: each item appears in the quote below)_
- **Product:** Quantum Workstation 12 Elite and Quantum Workstation Elite | Charlotte Frame Configuration (QPF5-CHARLOTTE) | Quantum Ventilation Module Lite | Quantum Pureflow Centrifugal Pumps (Centrifugal Blood Pump CP20; Centrifugal Blood Pump CP22; Centrifugal Blood Pump CP22 with Integrated Sensors; Quantum Centrifuge Drive CP 22) | Melbourne Transport Frame (QPF7-MELBOURNE) _(verified: each item appears in the quote below)_
- **FDA notes:** Identified models are subject to DWPE | Identified model is subject to DWPE | Identified model is subject to DWPE | Identified models are subject to DWPE | dentified model is subject to DWPE. _(verified: each item appears in the quote below)_

## What the source says

> SPECTRUM MEDICAL SRL Date Published : 05/19/2026 Via Di Mezzo 23 , Mirandola, Modena ITALY 74 D - - RY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Date Published: 05/19/2026 Desc: Quantum Workstation 12 Elite and Quantum Workstation Elite Notes: Identified models are subject to DWPE 74 D - - TQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Date Published: 05/19/2026 Desc: Charlotte Frame Configuration (QPF5-CHARLOTTE) Notes: Identified model is subject to DWPE 74 D - - TX Gas Control Unit, Cardiopulmonary Bypass Date Published: 05/19/2026 Desc: Quantum Ventilation Module Lite Notes: Identified model is subject to DWPE 74 K - - FM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Date Published: 05/19/2026 Desc: Quantum Pureflow Centrifugal Pumps (Centrifugal Blood Pump CP20; Centrifugal Blood Pump CP22; Centrifugal Blood Pump CP22 with Integrated Sensors; Quantum Centrifuge Drive CP 22) Notes: Identified models are subject to DWPE 74 K - - RI Accessory Equipment, Cardiopulmonary Bypass Date Published: 05/19/2026 Desc: Melbourne Transport Frame (QPF7-MELBOURNE) Notes: dentified model is subject to DWPE.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).