Recall Z-0224-2025 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Spectrum Medical Ltd.
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
| Date | Oct 24, 2024 (initiated Mar 13, 2023) |
| Status | Completed |
| Reason | The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock. |
| Root cause | Component design/selection |
| Action | All potentially affected product was identified. The firm corrected all products between 03/13/2024 and 08/07/2024 during service visits. |
| Quantity | 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, Pennsylvania, Tennessee, Texas, Utah, West Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173834 | Quantum Pump Console Spectrum Medical , Ltd., May 25, 2018 |