EDAN recalled 342 patient monitors on October 24, 2025, due to potential cybersecurity issues. Models affected include elite V5, elite V6, and elite V8. Healthcare providers and patients should stop using these devices immediately.
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 recall affects EDAN Patient Monitors models elite V5, elite V6, and elite V8, which were distributed worldwide, including various U.S. states and Mexico. They were sold for approximately $1,800.
The recall follows an FDA It Has Come to Our Attention letter indicating potential cybersecurity vulnerabilities that could compromise the device's functionality. These issues may hinder the monitor’s ability to accurately display vital signs.
There have been no reported injuries or deaths associated with this recall. The risk level is classified as high due to the potential impact on patient monitoring.
Patients and healthcare providers should stop using the recalled monitors immediately. Contact Edan Diagnostics or your healthcare provider for further instructions and follow the provided recall instructions.
For additional information, contact Edan Diagnostics at 1-800-XXX-XXXX or visit their website at www.edandiagnostics.com.
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