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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-1145-2026
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
14550
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: iM50 UDI-DI code: 06944413801622 Serial/Lot Numbers: 002327-M16803350001 002327-M16803350002 360069-M17707110001 333109-M16203920004 333109-M16203920005 333136-M16203910001 333136-M16203910002 333136-M16203910003 333136-M16203910004 333136-M16203910006 333136-M16203910007 333136-M16203910008 333136-M16203910009 333136-M16203910010 333136-M16203910005 333109-M16203920003 333109-M16203920002 333109-M16203920001 333109-M16802350004 333109-M16802350005 333109-M16802350006 333109-M16802350007 333109-M16802350008 333136-M16802360001 333136-M16802360002 333136-M16802360003 333136-M16802360004 333109-M16802350003 333136-M16802360005 333109-M16802350002 333109-M16802350001 333136-M16810700002 333136-M16810700003 333136-M16810700004 333136-M16810700005 333136-M16810700001 333136-M16A02590001 333136-M16A02590002 333136-M16A02590005 333136-M16A02590004 333136-M16A02590003 333136-M16A02590006 333136-M16A02590007 333136-M16A02590008 333136-M16A02590009 333136-M16A02590010 333136-M16B08530006 333136-M16B08530011 333136-M16B08530010 333136-M16B08530009 333136-M16B08530008 333136-M16B08530007 333136-M16B08530014 333136-M16B08530005 333136-M16B08530004 333136-M16B08530003 333136-M16B08530002 333136-M16B08530001 333109-M16B08540003 333109-M16B08540002 333109-M16B08540001 333136-M16B08530015 333136-M16B08530012 333136-M16B08530013 261054-M16C02640001 333136-M16B08550009 333136-M16B08550008 333136-M16B08550007 333136-M16B08550006 333136-M16B08550005 333136-M16B08550002 333136-M16B08550003 333136-M16B08550010 333136-M16B08550001 333109-M16B08560002 333109-M16B08560001 333136-M16B08550004 333136-M16B08550011 333136-M16B08550014 333136-M16B08550013 333136-M16B08550015 333136-M16B08550012 333109-M17201740005 333109-M17201740004 333109-M17201740003 333109-M17201740001 333109-M17201740002 261054-M17404380002 261054-M17404380001 261054-M17404380003 333152-M17606230003 333152-M17606230001 333152-M17606230004 333152-M17606230005 333152-M17606230002 333152-M17604540004 333152-M17604540005 333152-M17604540013 333152-M17604540007 333152-M17604540014 333152-M17604540001 333152-M17604540002 333152-M17604540010 333152-M17604540006 333152-M17604540012 333152-M17604540003 333152-M17604540011 333152-M17604540015 333152-M17604540008 333152-M17604540016 333152-M17604540009 333152-M17615040010 333152-M17615040004 333152-M17615040008 333152-M17615040003 333152-M17615040002 333152-M17615040005 333152-M17615040001 333152-M17615040009 333152-M17615040007 333152-M17615040006 333152-M17708870014 333152-M17708870004 333152-M17708870013 333152-M17708870005 333152-M17708870009 333153-M17708880003 333153-M17708880004 333153-M17708880005 333152-M17708870003 333152-M17708870011 333153-M17708880001 333152-M17708870001 333153-M17708880002 333152-M17708870012 333152-M17708870008 333152-M17708870006 333152-M17708870015 333152-M17708870007 333152-M17708870002 333152-M17708870010 333152-M17812870004 333153-M17812880003 333152-M17812870007 333152-M17812870006 333153-M17812880002 333152-M17812870001 333152-M17812870005 333152-M17812870003 333152-M17812870002 333153-M17812880001 333152-M17B07380003 333153-M17B07390010 333153-M17B07390009 333152-M17B07380007 333152-M17B07380005 333153-M17B07390007 333153-M17B07390005 333152-M17B07380014 333152-M17B07380013 333152-M17B07380011 333152-M17B07380004 333152-M17B07380009 333152-M17B07380015 333153-M17B07390004 333152-M17B07380006 333152-M17B07380002 333153-M17B07390008 333153-M17B07390002 333152-M17B07380010 333153-M17B07390003 333152-M17B07380012 333152-M17B07380008 333153-M17B07390001 333153-M17B07390006 333152-M17B07380001 261054-M17B09100003 261054-M17B09100002 261054-M17B09100004 261054-M17B09100001 333152-M18108230008 333152-M18108230007 333153-M18108210001 333153-M18108210002 333153-M18108210005 333152-M18108230001 261054-M18108220002 261054-M18108220001 333152-M18108230009 333152-M18108230005 333152-M18108230004 333152-M18108230010 333153-M18108210003 333153-M18108210004 333152-M18108230006 333152-M18108230003 333152-M181082…
UPC codes
06944413801622

Products covered by this recall

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, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. 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.

  • 06944413801622

Lot or batch code

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

  • 002327-M16803350001 002327-M16803350002 360069-M17707110001 3331

Model or item number

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

  • iM50
  • iM60
  • iM70

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 06944413801622; lot code 002327-M16803350001 002327-M16803350002 360069-M17707110001 3331; model number iM50, iM60, iM70. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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