Z-0224-2025Class II

Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and...

Name: Z-0224-2025 Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and...
Creator: Spectrum Medical Ltd.
Published: 2023-03-13
License: https://open.fda.gov/license/

Spectrum Medical Inc / initiated 2023-03-13 / Completed / root cause: design

FDA source

Spectrum Medical Ltd. began a recall of Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a)... on 2023-03-13. FDA classified it as Class II and gives the reason as "The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-0224-2025
Classification: Class II
Status: Completed
Initiated: 2023-03-13
Posted: 2024-10-24
Recalling firm: Spectrum Medical Inc
Product: 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
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: UDI/DI 05060434420770: Serial Numbers: a) AU6004040, AU6004041, AU6004042, AU6004043, AU6004044, AU6004046, AU6004050, AU6004051, AU6004052, AU6004053, AU6004054, AU6004056, AU6004057, AU6004058, AU6004060, AU6004061, AU6004062, AU6004063, AU6004064, AU6004065, AU6004066, AU6004069, AU6004070, AU6004071, AU6004072, AU6004073, AU6004074, AU6004075, AU6004136, AU6004137, AU6004138, AU6004139, AU6004140, AU6004141, AU6004142, AU6004143, AU6004144, AU6004145, AU6004146, AU6004147, AU6004148, AU6004159, AU6004160, AU6004161, AU6004162, AU6004167, AU6004168, AU6004169, AU6004170, AU6004171, AU6004172, AU6004173, AU6004174, AU6004175, AU6004176, AU6004177, AU6004178, AU6004179, AU6004180, AU6004181, AU6004182, AU6004183, AU6004184, AU6004185, AU6004186, AU6004187, AU6004188, AU6004195, AU6004197, AU6004198, AU6004200, AU6004201, AU6004202, AU6004203, AU6004204, AU6004205, AU6004207, AU6004332, AU6004333, AU6004348, AU6004349, AU6004350, AU6004352, AU6004353, AU6004354, AU6004532, AU6004577, AU6004578, AU6004579, AU6004580, AU6004587, AU6004588, AU6004590, AU6004591, AU6004603, AU6004604, AU6004605, AU6004606, AU6004607, AU6004609, AU6004610, AU6004613, AU6004731, AU6004771, AU6004773, AU6004776, AU6004777, AU6004778, AU6004779, AU6004781, AU6004782, AU6004919, AU6004920, AU6004921, AU6004922, AU6004923, AU6004924, AU6004925, AU6004926, AU6004927, AU6004929, AU6004930, AU6004955, AU6004957, AU6004958, AU6004960, AU6004963, AU6004966, AU6004968, AU6004970, AU6004971, AU6004972, AU6005010, AU6005021, AU6005022, AU6005023, AU6005024, AU6005025, AU6005026, AU6005027, AU6005028, AU6005029, AU6005030, AU6005037, AU6005038, AU6005039, AU6005040, AU6005041, AU6005042, AU6005057, AU6005065, AU6005109, AU6005110, AU6005118, AU6005124, AU6005125, AU6005355, AU6006351; Serial Numbers: b) AU8001273, AU8001275, AU8001346, AU8001347, AU8001348, AU8001359, AU8001360, AU8001366, AU8001403, AU8001406, AU8001407, AU8001446, AU8001447, AU8001449

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0224-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0224-2025	Class II	Completed	Voluntary: Firm initiated	2024-10-30	2024-10-24

Product code DTQ

K173834Class IIQuantum Pump ConsoleSpectrum Medical , Ltd. / cleared 2018-05-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)