FDAOctober 24, 2025device
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
edan diagnosticsedan
UPCs
06944413802179
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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