| | Class 2 Device Recall EDAN |  |
| Date Initiated by Firm | October 24, 2025 |
|---|
| Date Posted | January 22, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1140-2026 |
|---|
| Recall Event ID |
97879 |
| 510(K)Number | K102140 K173042 |
|---|
| Product Classification |
System, monitoring, perinatal - Product Code HGM
|
| 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 |
|---|
| Code Information |
EDAN Model: F3
UDI-DI code: 06944413800847
Serial/Lot Code:
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461234-M22603160001
560034-M17812060001
560034-M18700480001
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560034-M18908300002
560034-M20405450001
560034-M20809580001
560034-M20B12040001
560034-M20C16880001
560034-M22406140001
560034-M23401580001
EDAN Model: F2
UDI-DI code: 06944413800861
Serial/Lot Numbers:
460305-M15B02670001
460305-M15B02670002
460305-M15B02670003
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| FEI Number |
3009499478
|
Recalling Firm/
Manufacturer |
Edan Diagnostics
9833 Pacific Heights Blvd
San Diego CA 92121-4707
|
| For Additional Information Contact | Chao Lin
858-7503066 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| Action | On 10/24/2025, the firm emailed notifying customers of a product recall. On 11/06/2025, the firm emailed an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them of labeling issues involving cybersecurity which arose from a communication from the U.S. Food & Drug Administration.
-First issue involves an inappropriate publicly routable IP address that was used as an example in the user manual for demonstrating user-configurable IP settings and
Second issue involves an inappropriate publicly IP address that was used as the factory default configuration.
Customer are instructed to:
1. Immediately examine their inventory and quarantine product subject to correction.
2. If customers may have further distributed affected product, identify their customers and notify them at once of this product correction. The notification to their customers may be enhanced by including the enclosed URGENT MEDICAL DEVICE CORRECTION.
3. For affected product still in their inventory, place copy of the enclosed Notice Before Use and Corrigenda of User Manual into its package before distribution.
4. For affected product that has been distributed or is in use:
(1) Confirm that they have received and acknowledged Corrigenda of User Manual. Print out a copy, attach to the User Manual.
(2) Confirm the publicly routable IP address 202.114.4.* is NOT used in the User Maintain in the device. If 202.114.4.* is being used, change to appropriate IP settings of device in the Network Setup according to Instruction Instructions for IP Settings Configuration.
5. Complete the attached Acknowledgement and Receipt Form, sign it, and return a scanned copy to the sender of this notification by email.
For questions - Contact:
EDAN Instruments, Inc.
Monday to Friday 09:00-17:00 (UTC+8)
Tel:+86-0755-26898326
EDAN Diagnostics, Inc.
Monday to Friday 09:00-17:00 (PST)
Tel: 1-(858)-750-3066 |
|---|
| Quantity in Commerce | 3721 |
|---|
| 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = HGM
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