| | Class 2 Device Recall EDAN |  |
| Date Initiated by Firm | October 24, 2025 |
|---|
| Date Posted | January 22, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1149-2026 |
|---|
| Recall Event ID |
97879 |
| 510(K)Number | K232962 |
|---|
| Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
|
| Product | Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iX10, iX12, iX15
Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate.
Component: No |
|---|
| Code Information |
EDAN Model: iX10
UDI-DI code: 06944413815889
Serial/Lot Numbers:
262541-M24816120001
262541-M24A09820001
262541-M24B06240003
262541-M24B06240002
262541-M24B06240001
262541-M25110410016
262541-M25110420014
262541-M25110420008
262541-M25110420009
262541-M25110420024
262541-M25110420023
262541-M25110420025
262541-M25110420018
262541-M25110410001
262541-M25110410009
262541-M25110410003
262541-M25110410004
262541-M25110410011
262541-M25110410015
262541-M25110410020
262541-M25110410002
262541-M25110410012
262541-M25110410005
262541-M25110410013
262541-M25110410014
262541-M25110410007
262541-M25110410008
262541-M25110410017
262541-M25110410018
262541-M25110410019
262541-M25110410010
262541-M25110420011
262541-M25110410006
262541-M25110420007
262541-M25110420020
262541-M25110420013
262541-M25110420001
262541-M25110420019
262541-M25110420022
262541-M25110420003
262541-M25110420010
262541-M25110420015
262541-M25110420004
262541-M25110420016
262541-M25110420012
262541-M25110420005
262541-M25110420017
262541-M25110420021
262541-M25110420006
262541-M25110420002
269944-M25514090006
269944-M25514090002
269944-M25514090004
269944-M25514090008
269944-M25514090007
269944-M25514090001
269965-M25510270004
269965-M25510270003
269965-M25510270001
269944-M25514090009
269944-M25514090005
269944-M25514090010
269965-M25510270002
269965-M25510270005
269944-M25514090003
262541-M25514080006
262541-M25510240004
262541-M25510240010
262541-M25514080005
262541-M25514080004
262541-M25514080002
262541-M25514080013
262541-M25514080003
262541-M25510240012
262541-M25510240001
262541-M25510240008
262541-M25510240015
262541-M25510240006
262541-M25510240009
262541-M25514080008
262541-M25510240011
262541-M25514080012
262541-M25510240007
262541-M25510240002
262541-M25510240003
262541-M25514080009
262541-M25510240005
262541-M25514080011
262541-M25514080007
262541-M25514080001
262541-M25510240013
262541-M25510240014
262541-M25514080010
262541-M25510240016
262541-M25704070016
262541-M25704070008
262541-M25704060002
262541-M25704060013
262541-M25704070011
262541-M25704070010
262541-M25704070003
262541-M25704070002
262541-M25704070009
262541-M25704070007
262541-M25704070005
262541-M25704070001
262541-M25704060018
262541-M25704060024
262541-M25704060014
262541-M25704070020
262541-M25704070018
262541-M25704070023
262541-M25704070022
262541-M25704070021
262541-M25704070019
262541-M25704070013
262541-M25704070006
262541-M25704070004
262541-M25704070012
262541-M25704060006
262541-M25704060005
262541-M25704060010
262541-M25704060020
262541-M25704060023
262541-M25704060021
262541-M25704060009
262541-M25704070015
262541-M25704070017
262541-M25704070025
262541-M25704060004
262541-M25704060008
262541-M25704060012
262541-M25704060016
262541-M25704060022
262541-M25704060001
262541-M25704060007
262541-M25704060011
262541-M25704060017
262541-M25704060019
262541-M25704070014
262541-M25704070024
262541-M25704060003
262541-M25704060015
262541-M25704060025
EDAN Model: iX12
UDI-DI code: 06944413815896
Serial/Lot Numbers:
262542-M23808800001
262542-M24B06270001
262542-M24B06280001
262542-M24B06250001
262542-M24B06280002
262542-M24B06270002
262542-M24B06260001
262542-M24B06250002
262542-M25110440008
262542-M25110430024
262542-M25110430020
262542-M25110430009
262542-M25110430006
262542-M25110430001
262542-M25110440016
262542-M25110440010
262542-M25110440005
262542-M25110440003
262542-M25110440001
262542-M25110430021
262542-M25110430013
262542-M25110430007
262542-M25110440011
262542-M25110430003
262542-M25110440017
262542-M25110440015
262542-M25110440020
262542-M25110430005
262542-M25110430010
262542-M25110430012
262542-M25110430014
262542-M25110430018
262542-M25110440007
262542-M25110430011
262542-M25110430016
262542-M25110430017
262542-M25110440013
262542-M25110440018
262542-M25110430019
262542-M25110440019
262542-M25110440014
262542-M25110440006
262542-M25110430023
262542-M25110430015
262542-M25110430002
262542-M25110430022
262542-M25110440012
262542-M25110430004
262542-M25110440009
262542-M25110440004
262542-M25110440002
262542-M25110430025
262542-M25110430008
269943-M25514100009
269943-M25514100033
269963-M25510300013
269943-M25514100030
269943-M25514100031
269963-M25510300011
269963-M25510300026
269963-M25510300008
269943-M25514100040
269943-M25514100027
269943-M25514100005
269963-M25510300030
269963-M25510300005
269943-M25514100015
269963-M25510300029
269943-M25514100032
269943-M25514100037
269963-M25510300025
269963-M25510300028
269943-M25514100038
269963-M25510300012
269943-M25514100039
269943-M25514100034
269943-M25514100028
269963-M25510300003
269963-M25510300010
269963-M25510300014
269943-M25514100026
269963-M25510300002
269943-M25514100021
269943-M25514100001
269963-M25510300018
269943-M25514100003
269963-M25510300021
269963-M25510300016
269963-M25510300009
269943-M25514100020
269963-M25510300019
269943-M25514100012
269963-M25510300004
269943-M25514100035
269943-M25514100014
269963-M25510300017
269963-M25510300001
269963-M25510300023
269963-M25510300022
269963-M25510300007
269943-M25514100019
269943-M25514100007
269943-M25514100025
269943-M25514100013
269963-M25510300027
269963-M25510300015
269963-M25510300006
269943-M25514100029
269943-M25514100024
269943-M25514100022
269943-M25514100017
269943-M25514100004
269943-M25514100002
269943-M25514100008
269943-M25514100018
269943-M25514100006
269943-M25514100010
269943-M25514100011
269963-M25510300024
269963-M25510300020
269943-M25514100036
269943-M25514100023
269943-M25514100016
262542-M25510290001
262542-M25510280012
262542-M25510280015
262542-M25510280010
262542-M25510280011
262542-M25510290012
262542-M25510290005
262542-M25510290003
262542-M25510290002
262542-M25510280007
262542-M25510280005
262542-M25510290007
262542-M25510290006
262542-M25510280016
262542-M25510280004
262542-M25510280003
262542-M25510290011
262542-M25510290009
262542-M25510290010
262542-M25510280001
262542-M25510280002
262542-M25510280008
262542-M25510280009
262542-M25510280014
262542-M25510290013
262542-M25510280006
262542-M25510290008
262542-M25510290004
262542-M25510280013
262542-M25704090002
262542-M25704090015
262542-M25704090017
262542-M25704090004
262542-M25704090009
262542-M25704090024
262542-M25704090021
262542-M25704090014
262542-M25704090025
262542-M25704090007
262542-M25704090008
262542-M25704090003
262542-M25704090001
262542-M25704090019
262542-M25704090023
262542-M25704090011
262542-M25704090020
262542-M25704090010
262542-M25704090005
262542-M25704080020
262542-M25704090022
262542-M25704090012
262542-M25704090013
262542-M25704090016
262542-M25704090006
262542-M25704080009
262542-M25704080016
262542-M25704080018
262542-M25704080022
262542-M25704080008
262542-M25704080010
262542-M25704090018
262542-M25704080014
262542-M25704080012
262542-M25704080002
262542-M25704080015
262542-M25704080017
262542-M25704080023
262542-M25704080005
262542-M25704080004
262542-M25704080007
262542-M25704080021
262542-M25704080006
262542-M25704080001
262542-M25704080011
262542-M25704080024
262542-M25704080003
262542-M25704080025
262542-M25704080019
262542-M25704080013
EDAN Model: iX15
UDI-DI code: 06944413815902
Serial/Lot Numbers:
262543-M24B06290002
262543-M24B06290001
262543-M25110450003
262543-M25110450002
262543-M25110450001
262543-M25110450004
262543-M25110450005
262543-M25303610001
269961-M25510320004
269961-M25510320002
269961-M25510320010
269942-M25514110006
269961-M25510320008
269961-M25510320005
269961-M25510320011
269942-M25514110001
269942-M25514110003
269961-M25510320012
269961-M25510320013
269942-M25514110010
269961-M25510320009
269961-M25510320006
269961-M25510320001
269942-M25514110007
269942-M25514110008
269961-M25510320015
269961-M25510320003
269942-M25514110005
269961-M25510320014
269961-M25510320007
269942-M25514110004
269942-M25514110002
269942-M25514110009
|
| 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 | 379 |
|---|
| 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 = MHX
|
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