Recall Z-1140-2026— 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: K173042, K102140. Product: Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. 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- K173042 — Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
- K102140 — FETAL MONITORS, MODELS F2 AND F3
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: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. 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.