| | Class 2 Device Recall EDAN |  |
| Date Initiated by Firm | October 24, 2025 |
|---|
| Date Posted | January 22, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1141-2026 |
|---|
| Recall Event ID |
97879 |
| 510(K)Number | K150901 K173042 |
|---|
| Product Classification |
System, monitoring, perinatal - Product Code HGM
|
| Product | Brand Name: EDAN
Product Name: Fetal & Maternal Monitor
Model/Catalog Number: F6, F9, F6 Express, F9 Express
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: F9
UDI-DI code: 06944413800434
Serial/Lot Numbers:
460430-M16105660001
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560156-M17B10630034
560156-M17B10630035
560156-M17B10630036
EDAN Model: F9 Express
UDI-DI code: 06944413800441
Serial/Lot Numbers:
560157-M15A03570001
460418-M15B07460001
460418-M16501740001
460418-M16405110001
460418-M16405110002
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460077-M16B04200001
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460418-M16B13700001
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560039-M17906650005
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460246-M15300540001
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460995-M19902020002
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460984-M21107550002
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560039-M21700780005
560039-M21C11330012
560039-M21C11330014
560039-M21C11330015
560039-M21C11330007
560039-M21C11330003
560039-M21C11330008
560039-M21C11330010
560039-M21C11330009
560039-M21C11330013
560039-M21C11330002
560039-M21C11330004
560039-M21C11330005
560039-M21C11330001
560039-M21C11330006
560039-M21C11330011
560039-M22204450005
560039-M22204450001
560039-M22204450002
560039-M22204450003
560039-M22204450004
460984-M22208630003
460984-M22208630002
460984-M22208630001
460995-M22508300006
460995-M22508300001
460995-M22508300003
460995-M22508300005
460995-M22508300002
460995-M22508300004
460984-M22708780003
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460984-M22800330002
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560039-M23314110001
560039-M23314110002
560039-M23403990001
460984-M23713910001
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460984-M23713910007
460984-M23713910005
560039-K23900060001
560039-M23909480001
560039-M23909480002
560039-M23B04830006
560039-M23B04830005
560039-M23B04830003
560039-M23B04830001
560039-M23B04830002
560039-M23B04830004
560039-M23C12960002
560039-M23C12960004
560039-M23C12960005
560039-M23C12960001
560039-M23C12960003
560039-M23B19510004
560039-M23B19510005
560039-M23B19510006
560039-M23B19510003
560039-M23B19510001
560039-M23B19510002
560039-M24407390004
560039-M24407390005
560039-M24407390001
560039-M24407390002
560039-K24400290002
560039-K24400290001
560039-M24407390003
560039-K24400270001
460977-M24518330001
460977-M24518330002
460977-M24518330006
460977-M24518330007
460977-M24518330009
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460977-M24518330008
460977-M24518330012
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460977-M24518330005
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560039-M24706730004
560039-M24706730002
560039-M24706730007
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560039-M24706730001
560039-M24706730005
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560039-M24A17700001
560039-M24A17700002
560039-M24A17700007
560039-M24A17700008
560039-M24A17700009
560039-M24A17700003
560039-M24A17700004
560039-M24A17700005
560039-M24A17700006
560039-M24C01220001
560039-M24C01220002
560039-M24C01220005
560039-M24C01220018
560039-M24C01220019
560039-M24C01220007
560039-M24C01220009
560039-M24C01220013
560039-M24C01220014
560039-M24C01220016
560039-M24C01220003
560039-M24C01220004
560039-M24C01220006
560039-M24C01220010
560039-M24C01220017
560039-M24C01220008
560039-M24C01220011
560039-M24C01220012
560039-M24C01220015
560039-M24C01220020
560039-M24C15030003
560039-M24C15030011
560039-M24C15030004
560039-M24C15030005
560039-M24C15030001
560039-M24C15030006
560039-M24C15030009
560039-M24C15030010
560039-M24C15030002
560039-M24C15030007
560039-M24C15030008
560039-M24C18150001
461291-M25623120002
461291-M25623120004
461291-M25623120001
461291-M25623120003
EDAN Model: F6
UDI-DI code: 06944413800458
Serial/Lot Numbers:
560177-M15A03580001
560177-M15A03580002
560177-M15A03580003
560198-M15A03590001
560198-M15A03590002
560198-M15A03590003
560198-M15A03590004
560198-M15A03590005
560202-M15A03690001
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560202-M15A06660010
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460410-M15B00900001
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460059-M15B03800001
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560038-M25702770014
560038-M25702770015
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560038-M25720170006
560038-M25720170012
560038-M25720170002
560038-M25720170013
560038-M25720170003
560038-M25720170005
EDAN Model: F6 Express
UDI-DI code: 06944413800465
Serial/Lot Numbers:
460491-M16402060001
460491-M16402060002
460491-M16402060003
460491-M16402060004
460491-M16402060005
460491-M16402060006
460491-M16402060007
460491-M16402060008
460491-M16402060009
460491-M16402060010
460491-M16402060011
460491-M16402060012
460491-M16402060013
460491-M16402060014
460491-M16402060015
460491-M16402060016
460491-M16402060017
460491-M16402060018
460491-M16402060019
460491-M16402060020
460491-M16402060021
460491-M16402060022
460491-M16402060023
460491-M16402060024
460491-M16402060025
460491-M16402060026
460491-M16402060027
460491-M16402060028
460491-M16402060029
460491-M16402060030
460491-M16402060031
460491-M16402060032
460491-M16402060033
460491-M16402060034
460491-M16402060035
460491-M16402060036
460491-M16402060037
460491-M16402060038
460491-M16402060039
460491-M16402060040
460541-M16901440001
460541-M16901440002
460541-M16901440003
460541-M16901440004
460541-M16A07740001
460541-M16A07740002
460541-M16A07740003
460541-M16A07740004
460541-M16A07740005
460541-M16A07740006
460541-M16A07740007
460541-M16A07740008
460541-M16A07740009
460541-M16A07740010
460491-M17101130001
460491-M17105890001
460541-M17411540002
460541-M17411540005
460541-M17411540006
460541-M17411540001
460541-M17411540003
460541-M17411540004
460541-M17707990005
460541-M17707990002
460541-M17707990001
460541-M17707990003
460541-M17707990004
460541-M17707990006
460702-M17B00470004
460702-M17B00470002
460702-M17B00470001
460702-M17B00470005
460702-M17B00470003
460702-M17B00470006
460491-M18314590001
460491-M18314590002
560037-M18413730002
560037-M18413730001
560037-M18413730003
560037-M18413730004
560037-M19101320001
560037-M19101320002
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460993-M22413330003
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560037-M25305080003
560037-M25305080001
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560037-M25918430005
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560037-M25918430015
560037-M25918430004
560037-M25918430010
560037-M25918430011
560037-M25918430014
560037-M25918430020
560037-M25918430021
560037-M25918430024
560037-M25918430018
560037-M25918430001
560037-M25918430013
560037-M25918430023
560037-M25918430008
560037-M25918430002
560037-M25918430012
560037-M25918430017
560037-M25918430022
560037-M25918430006
560037-M25918430009
|
| 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 | 3518 |
|---|
| 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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