Spectrum Medical Ltd. · 89-08 · UNITED KINGDOM
For Spectrum Medical Ltd., import alert is 89-08; country is UNITED KINGDOM; 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)"; product is Quantum Workstation 12 Elite and Quantum Workstation Elite | Charlotte Frame Configuration (QPF5-CHARLOTTE) | Quantum PureFlow Standard Heat Exchanger (Model HX55V) | Quantum Ventilation Module Lite | Quantum SuperPAC CPB (CPB Tubing Set with Devices) | 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 - - TR Heat-Exchanger, Cardiopulmonary Bypass | 74 D - - TX Gas Control Unit, Cardiopulmonary Bypass | 74 D - - WF Catheter, Cannula And Tubing, Vascular, 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 Ashville Business Park Commerce Road , Gloucester, Gloucestershire UNITED KINGDOM, verified against its source on 2026-10-08.
- Firm
- Spectrum Medical Ltd. verified
- 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
- UNITED KINGDOM verified
- Address
- Ashville Business Park Commerce Road , Gloucester, Gloucestershire UNITED KINGDOM verified
- Date published
- 05/19/2026 verified
- Product code
- 74 D - - RY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 74 D - - TQ Console, Heart-Lung Machine, Cardiopulmonary Bypass | 74 D - - TR Heat-Exchanger, Cardiopulmonary Bypass | 74 D - - TX Gas Control Unit, Cardiopulmonary Bypass | 74 D - - WF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 74 K - - FM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 74 K - - RI Accessory Equipment, Cardiopulmonary Bypass each item verified
- Product
- Quantum Workstation 12 Elite and Quantum Workstation Elite | Charlotte Frame Configuration (QPF5-CHARLOTTE) | Quantum PureFlow Standard Heat Exchanger (Model HX55V) | Quantum Ventilation Module Lite | Quantum SuperPAC CPB (CPB Tubing Set with Devices) | 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) each item verified
- FDA notes
- Identified models are subject to DWPE | Identified model is subject to DWPE | Identified model is subject to DWPE | Identified model is subject to DWPE | Identified configurations that include a set of tubing and additional devices are subject to DWPE | Identified models are subject to DWPE | Identified model is subject to DWPE. each item verified
What the source says
Spectrum Medical Ltd. Date Published : 05/19/2026 Ashville Business Park Commerce Road , Gloucester, Gloucestershire UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-10-08
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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 - - TR Heat-Exchanger, Cardiopulmonary Bypass Date Published: 10/07/2026 Desc: Quantum PureFlow Standard Heat Exchanger (Model HX55V) 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 D - - WF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Date Published: 10/07/2026 Desc: Quantum SuperPAC CPB (CPB Tubing Set with Devices) Notes: Identified configurations that include a set of tubing and additional devices are 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: Identified model is subject to DWPE.
— all from accessdata.fda.gov, retrieved 2026-10-08
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html