EDAN recalled 195 units of its Central Monitoring System MFM-CMS on October 24, 2025, due to potential cybersecurity issues. The recall follows an FDA letter warning about vulnerabilities that could impact device functionality. Users must stop using the device immediately and follow the manufacturer’s instructions for a remedy.
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 recalled product is the EDAN Central Monitoring System, model MFM-CMS, with UDI-DI code 06944413800229. The system was distributed worldwide, including states such as California, Kentucky, and Texas, since its release.
The recall stems from potential cybersecurity issues identified in an FDA It Has Come to Our Attention Letter. These vulnerabilities could compromise the device's ability to manage information from connected medical devices.
There have been no reported injuries or incidents associated with this recall. However, the potential cybersecurity risk poses a significant safety concern.
Patients and healthcare providers should stop using the MFM-CMS immediately. Contact EDAN Diagnostics or your healthcare provider for specific instructions on how to proceed.
For more information, contact EDAN Diagnostics at their customer service number or visit their website. Consumers can also refer to the FDA recall page for updates.
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