Rapid Oxygen R15
RAPID OXYGEN INC · Model R15 · UDI-DI 10860466001808
Description
The R-15 oxygen generator provides on-demand oxygen delivered to the subject using an oxygen facemask. The R-15 oxygen generator consists of housing containing the oxygen generating chemical in mesh pouches, reaction regulating sealed liquid containing pouches, a lid, a water bag and a valve assembly with a compartment for the catalyst. The oxygen producing chemical, catalyst and water are isolated from each other during storage by placing each in separated sealed compartments. The compartments are connected by a valve that upon activation allows the water to flow through a chamber in the valve containing the catalyst and into the compartment in the housing with the mixture. The water distributes the catalyst through the compartment and submerses the oxygen generating chemical mixture and a portion of the sealed pouches. When the hydrogen peroxide contacts MnO2, the hydrogen peroxide is decomposed catalytically to water and oxygen.
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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