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Completed

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

FDA Recall Z-0224-2025 · Posted 2024-10-24

Recalling FirmSpectrum Medical Ltd.
Recall StatusCompleted
Product CodeDTQ
Date Initiated2023-03-13
Product Quantity172 units

Reason for Recall

The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.

Firm Action

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

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173834Quantum Pump ConsoleSpectrum Medical , Ltd. · 2018-05-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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