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EnsoTherapy
Ensodata, Inc. · Model 6.0 · UDI-DI 00864458000421
1
510(k) clearances
2,980
Adverse events (10 deaths)
24
Recalls
315
Facilities
Description
EnsoTherapy is a clinical decision support (CDS)/Medical Device Data System (MDDS) non-medical device product that allows clinicians, clinical support staff, or administrators to identify and prioritize patients that could benefit from sleep disorder treatment adherence support. Treatment and communication data are imported into the software component, which is used to generate compliance projections, risk scores, and prioritized tasks for each patient. Information and tasks generated are used by clinicians in their decisions on how to prioritize patient coaching outreach.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-08 | Radiometer Medical ApS | Due to potential software issue that may result in patient mix-up information. |
| 2023-02-06 | Biomerieux Inc | For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST r |
| 2021-09-02 | BioMerieux SA | Under certain conditions, there is a risk for a false negative result. |
| 2020-09-22 | Pentax of America Inc | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does |
| 2020-09-22 | Pentax of America Inc | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does |
| 2020-01-17 | Beckman Coulter Inc. | A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that |
| 2019-09-25 | ENDOTRONIX | The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix. |
| 2019-08-08 | Radiometer Medical ApS | The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some thir |
| 2019-05-20 | Opternative Inc | Lack of 510K clearance |
| 2017-12-06 | Intel-GE Care Innovations LLC | It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the back |
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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.