| | Class 2 Device Recall EDAN |  |
| Date Initiated by Firm | October 24, 2025 |
|---|
| Date Posted | January 22, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1154-2026 |
|---|
| Recall Event ID |
97879 |
| 510(K)Number | K113653 |
|---|
| Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
|
| Product | Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iM8, iM8A, iM8B
Product Description: iM8 Series Patient Monitor 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 abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models.
iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement.
iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models.
Component: No |
|---|
| Code Information |
EDAN Model: iM8
UDI-DI code: 06944413801592
Serial/Lot Numbers:
260645-M15C07240016
260645-M15C07240001
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360001-M24A19090019
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360001-M24C20530010
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360001-M25627280002
360001-M25627280001
360001-M25627280010
EDAN Model: iM8A
UDI-DI code: 06944413801608
Serial/Lot Numbers:
262028-M20411730007
262028-M20411730006
262028-M20411730024
262028-M20411730023
262028-M20411730019
262028-M20411730005
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360001-M20415950001
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262030-M21702080001
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262030-M21702080009
262030-M21702080017
262030-M21702080004
262030-M21702080010
262030-M21702080012
262030-M21702080018
262030-M21702080022
262030-M21702080003
262030-M21702080011
262030-M21702080015
262030-M21702080020
262030-M21702080028
262030-M21702080007
262030-M21702080014
262030-M21702080029
262029-M21702070017
262030-M21702080025
262029-K21700040001
262029-M21702070006
262029-M21702070009
262029-M20601160001
262029-M21702070002
262029-M21702070003
262030-M23913770001
262030-M23913770002
EDAN Model: iM8B
UDI-DI code: 06944413801615
Serial/Lot Numbers:
260133-M16906960001
260133-M16906960002
260133-M16905680001
260133-M16905680002
360001-M20811210001
360001-M20907160001
360001-M20914640003
360001-M20914640008
360001-M20914640002
360001-M20914640001
360001-M20914640007
360001-M20914640009
360001-M20914640010
360001-M20914640006
360001-M20914640004
360001-M20914640005
|
| 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 | 3141 |
|---|
| 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.
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| 510(K) Database | 510(K)s with Product Code = MHX
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