Class II U.S. Food and Drug Administration

Brand Name: EDAN Product Name: Patient Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA

Recall published 9 months ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1147-2026
Published
January 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Edan Diagnostics
Product type
Medical devices
Units affected
377
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: iM20 UDI-DI code: 06944413802179 Serial/Lot Numbers: 260502-M17A03230001 260374-M18401280001 260374-M18401280002 260374-M18407120001 260374-M18407120002 260374-M18613240001 260374-M18613240002 260374-M18A08010001 260374-M20506470001 260374-M20506470003 260374-M20506470005 260374-M20506470002 260374-M20506470004 260374-M18402820001 260374-M20B06690002 260374-M20B06690003 260374-M20B06690001 260374-M20C13130002 260374-M20C13130004 260374-M20C13130001 260374-M20C13130003 260374-M20C13130005 260374-M21108520006 260374-M21108520015 260374-M21108520009 260374-M21108520004 260374-M21108520001 260374-M21108520014 260374-M21108520011 260374-M21108520007 260374-M21108520002 260374-M21108520005 260374-M21108520003 260374-M21108520010 260374-M21108520012 260374-M21108520013 260374-M21108520008 260374-M21608850002 260374-M21616970003 260374-M21608850001 260374-M21608850005 260374-M21608850004 260374-M21616970002 260374-M21608850003 260374-M21616970001 260374-K21800220002 260374-K21800220001 260374-M21A04520003 260374-M21A04520002 260374-M21A04520001 260374-M22105780003 260374-M22105780001 260374-M22105780002 260374-M22301830005 260374-M22301830008 260374-M22301830002 260374-M22301830004 260374-M22301830001 260374-M22301830007 260374-M22301830009 260374-M22301830003 260374-M22301830006 260374-M22301830010 260374-M22405470001 260374-M22405470004 260374-M22405470002 260374-M22405470003 260374-M22405470005 260374-M22507870001 260374-M22511350001 260374-M22511350002 260374-M22511350004 260374-M22511350003 260374-M22511350005 260374-M22800760001 260374-M22812970001 260374-M22B02100004 260374-M22B02110003 260374-M22B02100005 260374-M22B02100002 260374-M22B02100001 260374-M22B02110001 260374-M22B02110002 260374-M22B02100003 260374-M22C07450001 260374-M22C07450003 260374-M22C07450002 260374-M22C07450004 260374-M22C07450009 260374-M22C07450006 260374-M22C07450005 260374-M22C07450010 260374-M22C07450007 260374-M22C07450008 260374-M23302060001 260374-M23227000002 260374-M23227000001 260374-M23713030001 260374-M23A11780001 260374-M23A11780002 260374-M23A11780004 260374-M23A11780003 260374-M23A11780005 260374-M23C18470001 260374-M23C15730002 260374-M23C15730001 260374-M24412120003 260374-M24412120002 260374-M24412120004 260374-M24412120005 260374-M24412120001 260374-M24607940001 260374-M24618190001 260374-M24816400002 260374-M24816400001 260374-M24816400005 260374-M24816400004 260374-M24816400003 260500-M17207700001 260374-M17211490003 260374-M17211490002 260374-M17211490004 260374-M17211490001 260374-M17211490005 260374-M18112460002 260374-M18112460001 260374-M18414750001 260374-M18414750002 260374-M19314330002 260374-M19314330001 260374-M19413110001 260374-M19507180001 260374-M19507180002 260374-M19908180003 260374-M19908180001 260374-M19908180004 260374-M19908180002 260374-M19B01600002 260374-M19B01600001 260374-M19B01600003 260374-M20202590002 260374-M20202590003 260374-M20202590001 260374-M20202590004 260374-M20202590005 260374-M20502980002 260374-M20502980004 260374-M20502980006 260374-M20502980007 260374-M20502980001 260374-M20502980005 260374-M20502980008 260374-M20502980003 260374-M20914770003 260374-M20914770001 260374-M20914770002 260374-M20918140001 260374-M20918140006 260374-M20918140003 260374-M20918140004 260374-M20918140002 260374-M20918140005 260374-M20B20310026 260374-M20B20310014 260374-M20B20310099 260374-M20B20310089 260374-M20B20310080 260374-M20B20310068 260374-M20B20310066 260374-M20B20310062 260374-M20B20310061 260374-M20B20310059 260374-M20B20310015 260374-M20B20310094 260374-M20B20310081 260374-M20B20310050 260374-M20B20310049 260374-M20B20310054 260374-M20B20310060 260374-M20B20310085 260374-M20B20310095 260374-M20B20310003 260374-M20B20310005 260374-M20B20310007 260374-M20B20310017 260374-M20B20310020 260374-M20B20310029 260374-M20B20310030 260374-M20B20310039 260374-M20B20310040 260374-M20B20310013 260374-M20B20310044 260374-M20B20310034 260374-M20B20310088 260374-M20B20310019 260374-M20B20310074 260374-M20B203…
UPC codes
06944413802179

Products covered by this recall

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 (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. Component: No

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 06944413802179

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 260502-M17A03230001 260374-M18401280001 260374-M18401280002 2603

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Edan Diagnostics — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Edan Diagnostics — 9833 Pacific Heights Blvd, San Diego, CA, 92121-4707

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Edan Diagnostics medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 06944413802179; lot code 260502-M17A03230001 260374-M18401280001 260374-M18401280002 2603. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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