Home › ZOE MEDICAL INCORPORATED › Ultraview DM3
Ultraview DM3
ZOE MEDICAL INCORPORATED · Model 91330-M · UDI-DI 00851920007002
1
510(k) clearances
13,819
Adverse events (360 deaths)
128
Recalls
399
Facilities
Description
The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-06-23 | Covidien | Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highligh |
| 2024-09-27 | Accriva Diagnostics, Inc. | Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than |
| 2024-09-18 | Nihon Kohden America Inc | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. |
| 2024-09-18 | Nihon Kohden America Inc | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. |
| 2024-08-13 | Zoe Medical Incorporated | This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life. |
| 2024-08-13 | Zoe Medical Incorporated | This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.