EDAN recalled 136 vital signs monitors on October 24, 2025, due to potential cybersecurity issues. The devices include models iM3s, iM3As, iM3Bs, and iHM3s. Patients and healthcare providers must stop using these monitors immediately and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Edan Diagnostics or your healthcare provider for instructions. Notification method: Letter
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The EDAN vital signs monitors are used to measure and store vital physiological parameters for both adults and pediatric patients. These devices are essential in clinical settings for ongoing patient monitoring.
The monitors may have cybersecurity vulnerabilities that could allow unauthorized access to sensitive patient data or interfere with proper device function, potentially leading to improper patient care.
This recall is not part of a broader industry pattern.
Consumers must stop using the devices immediately, which may disrupt patient monitoring in healthcare settings, leading to potential safety risks.
Serial numbers and model numbers can typically be found on the back or underside of the device.
Expect the refund or replacement process to take about 4-6 weeks after your device has been returned.
Keep copies of all communication regarding the recall, including emails, letters, and any relevant documentation.
The affected models include iM3s, iM3As, iM3Bs, and iHM3s. These devices are used for measuring and storing physiological parameters in adults and pediatrics. The monitors were distributed worldwide, including states like California, Florida, and Texas.
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