Edan Diagnostics Recall: Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog
Edan Diagnostics Recall: Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Edan Diagnostics; Product: Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor
| Recalling firm | Edan Diagnostics |
|---|---|
| Product | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico. |
| Recall initiated | 20251024 |
| Recall number | Z-1142-2026 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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