EDAN recalled 354 units of its M3B Vital Signs Monitor on October 24, 2025, due to potential cybersecurity vulnerabilities. The recall affects devices distributed nationwide in the U.S. and Mexico. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's instructions for returning the product.
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 M3B Vital Signs Monitor continuously tracks arterial blood oxygen saturation (SpO2), pulse rate, and CO2 levels. The recall affects 354 units sold in the U.S. states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI, and in Mexico.
The recall follows an FDA It Has Come to Our Attention Letter regarding potential cybersecurity issues. These vulnerabilities may compromise the device's functionality, posing risks to patient monitoring.
No injuries or incidents have been reported related to this issue. The recall emphasizes the importance of addressing cybersecurity vulnerabilities in medical devices.
Stop using the M3B Vital Signs Monitor immediately. Contact Edan Diagnostics or your healthcare provider for further instructions on returning the device and obtaining a refund.
For further assistance, call Edan Diagnostics at 1-800-XXX-XXXX or visit their website at www.edandiagnostics.com.
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