Recall Z-1143-2026— Edan Diagnostics

Name: FDA recall Z-1143-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-24

Class II · Ongoing

Class II FDA medical device recall by Edan Diagnostics, initiated 2025-10-24. It names one FDA 510(k) clearance: K180380. Product: Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. 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..

Recalling firm: Edan Diagnostics
Classification: Class II
Status: Ongoing
Initiated: 2025-10-24
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K180380 — vital signs monitorEdan Instruments, Inc.·cleared 2018-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.