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 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.
The recall stems from a letter received from the FDA regarding potential cybersecurity vulnerabilities. These issues could compromise patient data and device integrity.
No specific incidents of harm or injury have been reported related to this recall. However, the potential risk of cybersecurity issues poses a high hazard level.
Stop using the device immediately. Follow the instructions provided by EDAN Diagnostics and contact your healthcare provider for further guidance.
For more information, contact Edan Diagnostics at the provided website or follow recall instructions via the FDA's official notification.
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