Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor

Recalling company

Edan Diagnostics

Product

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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Oct 24, 2025

Reported

Jan 28, 2026

Distribution

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

Status

Ongoing

Quantity

342

Lot / codes

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 2

Company location

San Diego, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-1146-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1146-2026 in the FDA Enforcement Report. Also see FDA recall press releases.