Recall Z-1147-2026
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: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No
Codes / lots: EDAN Model: iM20 UDI-DI code: 06944413802179 Serial/Lot Numbers: 260502-M17A03230001 260374-M18401280001 260374-M18401280002 260374-M18407120001 260374-M18407120002 260374-M18613240001 260374-M18613240002 260374-M18A08010001 260374-M20506470001 260374-M20506470003 260374-M20506470005 260374-M20506470002 260374-M20506470004 260374-M18402820001 260374-M20B06690002 260374-M20B06690003 260374-M20B06690001 260374-M20C13130002 260374-M20C13130004 260374-M20C13130001 260374-M20C13130003 260374-M20C13130005 260374-M21108520006 260374-M21108520015 260374-M21108520009 260374-M21108520004 260374-M21108520001 260374-M21108520014 260374-M21108520011 260374-M21108520007 260374-M21108520002 260374-M21108520005 260374-M21108520003 260374-M21108520010 260374-M21108520012 260374-M21108520013 260374-M21108520008 260374-M21608850002 260374-M21616970003 260374-M21608850001 260374-M21608850005 260374-M21608850004 260374-M21616970002 260374-M21608850003 260374-M21616970001 260374-K21800220002 260374-K21800220001 260374-M21A04520003 260374-M21A04520002 260374-M21A04520001 260374-M22105780003 260374-M22105780001 260374-M22105780002 260374-M22301830005 260374-M22301830008 260374-M22301830002…
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-1147-2026
- Initiated
- October 24, 2025
- Posted by FDA
- January 22, 2026
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Quantity
- 377
- 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-1144-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As…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-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 |