Recall Z-1144-2026
Edan Diagnostics · initiated October 24, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No
Codes / lots: EDAN Model: iM3s UDI-DI code: 06944413811171 Serial/Lot Numbers: 262825-H24701480005 262825-H24701480001 262825-H24701480002 262825-H24701480007 262825-H24701480010 262825-H24701480009 262825-H24701480008 262825-H24701480004 262825-H24701480003 262825-H24701480006 262825-H24802410006 262825-H24802410003 262825-H24802410007 262825-H24802410009 262825-H24802410010 262825-H24802410002 262825-H24802410005 262825-H24802410001 262825-H24802410008 262825-H24802410004 261573-M21708880001 261573-M21803610001 261573-M21C04280007 261573-M21C04280003 261573-M21C04280004 261573-M21C04280008 261573-M21C04280002 261573-M21C04280012 261573-M21C04280011 261573-M21C04280010 261573-M21C04280009 261573-M21C04280006 261573-M21C04280013 261573-M21C04280001 261573-M21C04280014 261573-M21C04280005 261573-M21C04280015 261573-M22701100009 261573-M22701100014 261573-M22701100019 261573-M22701100022 261573-M22701100025 261573-M22701100004 261573-M22701100021 261573-M22701100018 261573-M22701100008 261573-M22701100001 261573-M22701100020 261573-M22701100012 261573-M22701100005 261573-M22701100002 261573-M22701100011 261573-M22701100024 261573-M22701100013 261573-M22701100015 261573-M22701100023…
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: Device Design
Action taken
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
Details
- Recall number
- Z-1144-2026
- Initiated
- October 24, 2025
- Posted by FDA
- January 22, 2026
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Quantity
- 136
- 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.
- Recalling firm
- Edan Diagnostics, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1140-2026 Class II | Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1141-2026 Class II | Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1142-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1143-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1145-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1146-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1147-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1148-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1149-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1150-2026 Class II | Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1151-2026 Class II | Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1152-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1153-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1154-2026 Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |
| Z-1155-2026 Class II | Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | 10/24/2025Open, Classified |