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DCX Disposable Cassette

INSTITUT GEORGES LOPEZ · Model DCX · UDI-DI 13700911900577

KDN Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The DCX Disposable Cassette is a sterile, disposable and single-use, organ cassette, which is used with a RM4 Control Unit, the whole constituting a system called RM4 Kidney Perfusion System. This organ cassette is intended to receive one or two kidneys from the same donor. The RM4 Kidney Perfusion System, is a lightweight and compact renal perfusion system intended to provide controlled perfusion of a hypothermic physiologic solution for the preservation of donor kidney organs before transplantation into the recipient This system controls kidney perfusion of hypothermic physiologic solutions and monitors, displays, trends, and saves the perfusion parameters. To complete this set, various cannulas/clamps for arterial cannulation of the kidneys to the perfusate circuit into the cassette are used. They’re not provided with the DCX disposable cassette.

Recalls

Date	Firm	Reason
2026-07-20	Paragonix Technologies Inc.	Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
2025-06-12	Bridge to Life Ltd	The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine
2022-03-21	Waters Medical Systems LLC	There is a potential for the WCM cassette pump head leaking solution.
2020-01-30	Organ Recovery Systems, Inc.	Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
2018-02-26	Preservation Solutions, Inc.	Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..
2010-09-24	Preservation Solutions Inc	Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.