Rhythm Healthcare, LLC
Rhythm Healthcare, LLC · Model LM5BA · UDI-DI 00860014866548
Description
The Rhythm Healthcare LM5BA is a stationary (home-use) continuous-flow oxygen concentrator designed to provide supplemental oxygen therapy in residential, nursing home or other non-acute care settings. The device uses the pressure swing adsorption (PSA) principle to separate oxygen from ambient air via molecular sieve beds. The LM5BA delivers oxygen at a continuous flow rate of up to 5 liters per minute, with an output oxygen concentration of approximately 93% ± 3% under rated conditions. The device is intended for use by adult, geriatric, and pediatric patients under the prescription and supervision of a qualified physician. It is not intended to sustain or support life in the sense of life-support systems. Key features include a user-friendly control panel, audible and visual alarms for temperature, oxygen purity, high/low pressure, power failure and blockage, low noise operation, high output pressure design, and optional accessories such as a transfill rack. Typical specifications: • Flow rate: up to 5
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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