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Oxyensure AC/DC Charger US
RESMED ASIA PTE. LTD. · Model 40106 · UDI-DI 09353645401062
10
510(k) clearances
52,785
Adverse events (519 deaths)
44
Recalls
85
Facilities
Description
Oxyensure POC AC/DC Charger US (AMO)
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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Get your free API keyRead the docsData 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.