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-1154-2026
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
3141
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: iM8 UDI-DI code: 06944413801592 Serial/Lot Numbers: 260645-M15C07240016 260645-M15C07240001 260645-M15C07240004 260645-M15C07240005 260645-M15C07240017 260645-M15C07240006 260645-M15C07240007 260645-M15C07240008 260645-M15C07240015 260645-M15C07240009 260645-M15C07240018 260645-M15C07240019 260645-M15C07240020 260645-M15C07240010 260645-M15C07240011 260645-M15C07240012 260645-M15C07240013 260645-M15C07240014 260645-M15C07240002 260645-M15C07240003 260645-M16200530008 260645-M16200530007 260645-M16200530006 260645-M16200530005 260645-M16200530001 260645-M16200530003 260645-M16200530002 260645-M16200530004 260605-M16304610008 260605-M16304610010 260605-M16304610007 260605-M16304610009 260605-M16304610006 260605-M16304610001 260605-M16304610004 260605-M16304610003 260605-M16304610002 260605-M16304610005 260605-K16300150005 260605-K16300150006 260605-K16300150007 260605-K16300150008 260605-K16300150009 260605-K16300150010 260605-K16300150004 260645-M16203940001 260645-M16203940003 260645-M16203940005 260645-M16203940006 260645-M16203940007 260645-M16203940008 260645-M16203940002 260605-K16300150003 260605-K16300150002 260605-K16300150001 260645-M16203940009 260645-M16203940010 260645-M16203940004 260645-M16203940012 260645-M16203940011 260605-M16313860011 260605-M16313860018 260605-M16313860017 260605-M16313860016 260605-M16313860019 260605-M16313860015 260605-M16313860014 260605-M16313860013 260605-M16313860012 260605-M16313860010 260605-M16313860005 260605-M16313860008 260605-M16313860007 260605-M16313860006 260605-M16313860020 260605-M16313860004 260605-M16313860003 260605-M16313860002 260605-M16313860001 260605-M16313860009 260605-M16314840022 260605-M16314840023 260605-M16314840024 260605-M16314840025 260605-M16314840026 260605-M16314840027 260605-M16314840030 260605-M16314840029 260605-M16314840021 260645-M16314850001 260645-M16314850002 260645-M16314850003 260645-M16314850004 260645-M16314850005 260605-M16314840028 260605-M16314840020 260605-M16314840016 260605-M16314840018 260605-M16314840001 260605-M16314840002 260605-M16314840003 260605-M16314840004 260605-M16314840005 260605-M16314840006 260605-M16314840019 260605-M16314840007 260605-M16314840009 260605-M16314840011 260605-M16314840013 260605-M16314840014 260605-M16314840015 260605-M16314840017 260605-M16314840008 260605-M16314840010 260605-M16314840012 260605-M16406990019 260605-M16406990018 260605-M16406990016 260605-M16406990013 260605-M16406990015 260605-M16406990014 260605-M16406990017 260605-M16406990020 260645-M16406980017 260645-M16406980002 260645-M16406980020 260645-M16406980019 260645-M16406980018 260605-M16406990012 260645-M16406980016 260645-M16406980015 260645-M16406980014 260645-M16406980013 260645-M16406980001 260645-M16406980012 260645-M16406980010 260645-M16406980009 260645-M16406980008 260645-M16406980007 260645-M16406980006 260645-M16406980005 260645-M16406980004 260645-M16406980003 260645-M16406980011 260605-M16406990011 260605-M16406990004 260605-M16406990009 260605-M16406990001 260605-M16406990002 260605-M16406990003 260605-M16406990005 260605-M16406990006 260605-M16406990007 260605-M16406990008 260605-M16406990010 260645-M16407130030 260645-M16407130028 260645-M16407130026 260645-M16407130025 260645-M16407130024 260645-M16407130023 260645-M16407130022 260645-M16407130021 260645-M16407130020 260645-M16407130019 260645-M16407130018 260645-M16407130027 260645-M16407130017 260645-M16407130016 260645-M16407130029 260645-M16407130014 260605-M16407120010 260605-M16407120009 260605-M16407120008 260605-M16407120007 260605-M16407120006 260605-M16407120005 260605-M16407120004 260605-M16407120003 260605-M16407120002 260645-M16407130015 260605-M16407120011 260605-M16407120012 260605-M16407120001 260605-M16407120014 260605-M16407120013 260645-M16407130013 260645-M16407130012 260645-M16407130011 260645-M16407130010 260645-M16407130009 260645-M16407130007 260645-M16407130006 260645-M16407130005 260645-M16407130004 260645-M16407130008 260645-M1640713…
UPC codes
06944413801592

Products covered by this recall

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement. iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models. Component: No

Check your product

The notice names 5 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.

  • 06944413801592

Lot or batch code

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

  • 260645-M15C07240016 260645-M15C07240001 260645-M15C07240004 2606

Model or item number

On the rating label, the box or the instruction sheet.

  • iM8
  • iM8A
  • iM8B

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 06944413801592; lot code 260645-M15C07240016 260645-M15C07240001 260645-M15C07240004 2606; model number iM8, iM8A, iM8B. 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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