Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial c
FDA device recall Z-0224-2025 · posted 2024-10-24 · Completed
Recall details
- Recalling firm
- Spectrum Medical Ltd.
- Reason for recall
- The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
- Action taken
- All potentially affected product was identified. The firm corrected all products between 03/13/2024 and 08/07/2024 during service visits.
- Root cause
- Component design/selection
- Status
- Completed
- Product code
- DTQ
- Quantity affected
- 172 units
- Distribution
- US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylva
- Date initiated
- 2023-03-13
- Date posted
- 2024-10-24
- Location
- Gloucester, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Quantum Pump Console (K173834) | Spectrum Medical , Ltd. | 2018-05-25 |