Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor…
Edan Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edan Diagnostics · 9833 Pacific Heights Blvd · San Diego, CA · 92121-4707
Is this the product you have?
- Brand NameEDAN
- Product NamePatient
- Monitor Model/Catalog NumberiM20
- Product DescriptionThe 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 (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment
- ComponentNo
- Lot codes and dates
- EDAN ModeliM20
- UDI-DI code06944413802179
- Serial/Lot Numbers
377 of 377 codes
260502-M17A03230001260374-M18401280001260374-M18401280002260374-M18407120001260374-M18407120002260374-M18613240001260374-M18613240002260374-M18A08010001260374-M20506470001260374-M20506470003260374-M20506470005260374-M20506470002260374-M20506470004260374-M18402820001260374-M20B06690002260374-M20B06690003260374-M20B06690001260374-M20C13130002260374-M20C13130004260374-M20C13130001260374-M20C13130003260374-M20C13130005260374-M21108520006260374-M21108520015260374-M21108520009260374-M21108520004260374-M21108520001260374-M21108520014260374-M21108520011260374-M21108520007260374-M21108520002260374-M21108520005260374-M21108520003260374-M21108520010260374-M21108520012260374-M21108520013260374-M21108520008260374-M21608850002260374-M21616970003260374-M21608850001260374-M21608850005260374-M21608850004260374-M21616970002260374-M21608850003260374-M21616970001260374-K21800220002260374-K21800220001260374-M21A04520003260374-M21A04520002260374-M21A04520001260374-M22105780003260374-M22105780001260374-M22105780002260374-M22301830005260374-M22301830008260374-M22301830002260374-M22301830004260374-M22301830001260374-M22301830007260374-M22301830009
- Amount recalled
- 377
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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