Spectrum Medical Ltd. · 89-08 · UNITED KINGDOM
For Spectrum Medical Ltd. · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; 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 Ashville Business Park Commerce Road , Gloucester, Gloucestershire UNITED KINGDOM, verified against its source on 2026-09-16.
- 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 - - TX Gas Control Unit, 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 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) each item verified
- 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 | 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 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: Identified model is subject to DWPE.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html