Recall Z-1144-2026— Edan Diagnostics
Class II · Ongoing
Class II FDA medical device recall by Edan Diagnostics, initiated 2025-10-24. It names 2 FDA 510(k) clearances: K233038, K202892. Product: Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. 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
2 on FDA's record- K233038 — Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
- K202892 — Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
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: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. 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.