Recall Z-1141-2026
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: 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
Codes / lots: EDAN Model: F9 UDI-DI code: 06944413800434 Serial/Lot Numbers: 460430-M16105660001 460430-M16700280001 460475-M16605590001 460475-M16605590002 460475-M16605590003 460475-M16605590004 460475-M16806530001 460475-M16806530002 460476-M16B07550001 460476-M16B07550002 460476-M16B07550003 460476-M17402630001 460476-M17402630002 460476-M17402630003 460476-M17402630004 460476-M17402630005 460476-M17607650001 460476-M17607650002 460476-M17607650003 460476-M17607650004 460476-M17607650005 460476-M17607650006 460476-M17607650007 460476-M17607650008 460476-M17607650009 460476-M17607650010 460517-M16804200001 460688-M17A07770001 460688-M17A07770002 460688-M17A07770003 460723-M17904190001 460945-M18200660001 460945-M18200660002 460945-M18200660003 460945-M18200660004 460945-M18200660005 460945-M18200660006 460945-M18200660007 460945-M18200660008 460945-M18200660009 460945-M18200660010 460945-M18200660011 460945-M18200660012 460945-M18200660013 460945-M18200660014 460945-M18200660015 460945-M18200660016 460945-M18200660017 460945-M18200660018 460945-M18200660019 460945-M18200660020 460945-M18200660021 460945-M18200660022 460945-M18200660023 460945-M18200660024 460945-M18200660025…
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-1141-2026
- Initiated
- October 24, 2025
- Posted by FDA
- January 22, 2026
- Product code
- HGM – System, Monitoring, Perinatal
- Quantity
- 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.
- 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-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-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 |