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-1146-2026
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
342
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: elite V8 UDI-DI code: 06944413801707 Serial/Lot Numbers: 260342-M17B09290001 002338-M23226990001 002338-M23226990002 002338-M23226990004 002338-M23226990003 002338-M23812870001 002338-M23C15870001 002338-M24A12130001 260342-M16506570001 260342-M15A03180001 002338-K22100150003 002338-K22100150004 002338-K22100150002 002338-K22100150001 261241-M22701020001 002338-M25705810020 002338-M25705810021 002338-M25705810011 002338-M25705810003 002338-M25705810013 002338-M25705810029 002338-M25705810033 002338-M25705810001 002338-M25705810010 002338-M25705810009 002338-M25705810004 002338-M25705810012 002338-M25705810018 002338-M25705810032 002338-M25705810017 002338-M25705810019 002338-M25705810024 002338-M25705810030 002338-M25705810031 002338-M25705810025 002338-M25705810016 002338-M25705810008 002338-M25705810006 002338-M25705810002 002338-M25705810028 002338-M25705810027 002338-M25705810022 002338-M25705810026 002338-M25705810023 002338-M25705810015 002338-M25705810014 002338-M25705810005 002338-M25705810007 002338-M25908680004 002338-M25908680003 002338-M25908680002 002338-M25908680001 EDAN Model: elite V5 UDI-DI code: 06944413802155 Serial/Lot Numbers: 260586-M17211520002 260586-M17211520006 260586-M17211520004 260586-M17211520008 260586-M17211520001 260586-M17211520009 260586-M17211520007 260586-M17211520003 260586-M17211520010 260586-M17211520005 260588-M17902120009 260588-M17902120002 260588-M17902120008 260588-M17902120001 260588-M17902120003 260588-M17902120006 260588-M17902120007 260588-M17902120004 260588-M17902120005 260588-M17902120010 260586-M19413090016 260586-M19413090007 260586-M19413090017 260586-M19413090006 260586-M19413090010 260586-M19413090014 260586-M19413090011 260586-M19413090008 260586-M19413090004 260586-M19413090019 260586-M19413090012 260586-M19413090003 260586-M19413090013 260586-M19413090009 260586-M19413090005 260586-M19413090002 260586-M19413090018 260586-M19413090001 260586-M19413090020 260586-M19413090015 260586-M19507110023 260586-M19507110013 260586-M19507110005 260586-M19507110009 260586-M19507110004 260586-M19507110019 260586-M19507110018 260586-M19507110024 260586-M19507110003 260586-M19507110008 260586-M19507110020 260586-M19507110014 260586-M19507110001 260586-M19507110002 260586-M19507110016 260586-M19507110010 260586-M19507110011 260586-M19507110012 260586-M19507110015 260586-M19507110021 260586-M19507110022 260586-M19507110007 260586-M19507110006 260586-M19507110025 260586-M19507110017 260586-M19604520007 260586-M19604520005 260586-M19604520006 260586-M19604520008 260586-M19604520001 260586-M19604520011 260586-M19604520010 260586-M19604520003 260586-M19604520009 260586-M19604520002 260586-M19604520004 260586-M19701080013 260586-M19702060010 260586-M19702060002 260586-M19702060003 260586-M19702060006 260586-M19702060013 260586-M19702060014 260586-M19701080004 260586-M19701080010 260586-M19701080011 260586-M19701080018 260586-M19701080003 260586-M19702060004 260586-M19701080007 260586-M19702060007 260586-M19701080008 260586-M19701080005 260586-M19701080009 260586-M19702060005 260586-M19702060015 260586-M19701080002 260586-M19701080019 260586-M19701080012 260586-M19702060001 260586-M19702060011 260586-M19701080020 260586-M19702060008 260586-M19701080014 260586-M19701080016 260586-M19702060009 260586-M19702060012 260586-M19701080001 260586-M19701080015 260586-M19701080006 260586-M19701080017 260586-M19805320026 260586-M19805320038 260586-M19805320024 260586-M19805320014 260586-M19805320001 260586-M19805320055 260586-M19805320046 260586-M19805320045 260586-M19805320054 260586-M19805320015 260586-M19805320023 260586-M19805320020 260586-M19805320016 260586-M19805320004 260586-M19805320008 260586-M19805320053 260586-M19805320050 260586-M19805320002 260586-M19805320048 260586-M19805320025 260586-M19805320009 260586-M19805320011 260586-M19805320027 260586-M19805320043 260586-M19805320052 260586-M19805320051 260586-M19805320041 260586-M19805320031 260586-M19805320029 260586-M19805320022 2…
UPC codes
06944413801707, 06944413802155

Products covered by this recall

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which 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 V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No

Check your product

The notice names 6 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.

  • 06944413801707
  • 06944413802155

Lot or batch code

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

  • 260342-M17B09290001 002338-M23226990001 002338-M23226990002 0023
  • 260586-M17211520002 260586-M17211520006 260586-M17211520004 2605

Model or item number

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

  • elite V5
  • elite V6

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 the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

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 06944413801707, 06944413802155; lot code 260342-M17B09290001 002338-M23226990001 002338-M23226990002 0023, 260586-M17211520002 260586-M17211520006 260586-M17211520004 2605; model number elite V5, elite V6. 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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