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Rhythm Healthcare, LLC

Rhythm Healthcare, LLC · Model LM5BA · UDI-DI 00850083102944

CAW Prescription

510(k) clearances

52,921

Adverse events (527 deaths)

Recalls

Facilities

Description

The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce oxygen. The device can separate nitrogen by absorbing through the molecular sieve when the room air enters the device and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 5L/min.

Recalls

Date	Firm	Reason
2026-02-04	3B Medical, Inc.	Devices which did not meet internal quality specifications were inadvertently distributed.
2025-10-07	Philips Respironics, Inc.	Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in
2025-05-08	Ohio Medical Corporation	Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purit
2025-04-11	Medical Depot Inc.	Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
2024-12-09	JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD	Oxygen concentrator may melt or catch on fire during use.
2024-10-04	Caire, Inc.	Potential failure of affected units to recharge the battery of the oxygen concentrators.
2024-10-04	Caire, Inc.	Potential failure of affected units to recharge the battery of the oxygen concentrators.
2024-10-04	Caire, Inc.	Potential failure of affected units to recharge the battery of the oxygen concentrators.
2024-10-04	Caire, Inc.	Potential failure of affected units to recharge the battery of the oxygen concentrators.
2023-03-09	DeVilbiss Healthcare LLC	The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

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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.