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FDAOctober 24, 2025device

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, disp...

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

06944413801622

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, disp... — Recall Details · AllClear