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FDAOctober 24, 2025device

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyz...

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

069444138158890694441381589606944413815902

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: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyz... — Recall Details · AllClear