Recall Z-1145-2026
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: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 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
Codes / lots: EDAN Model: iM50 UDI-DI code: 06944413801622 Serial/Lot Numbers: 002327-M16803350001 002327-M16803350002 360069-M17707110001 333109-M16203920004 333109-M16203920005 333136-M16203910001 333136-M16203910002 333136-M16203910003 333136-M16203910004 333136-M16203910006 333136-M16203910007 333136-M16203910008 333136-M16203910009 333136-M16203910010 333136-M16203910005 333109-M16203920003 333109-M16203920002 333109-M16203920001 333109-M16802350004 333109-M16802350005 333109-M16802350006 333109-M16802350007 333109-M16802350008 333136-M16802360001 333136-M16802360002 333136-M16802360003 333136-M16802360004 333109-M16802350003 333136-M16802360005 333109-M16802350002 333109-M16802350001 333136-M16810700002 333136-M16810700003 333136-M16810700004 333136-M16810700005 333136-M16810700001 333136-M16A02590001 333136-M16A02590002 333136-M16A02590005 333136-M16A02590004 333136-M16A02590003 333136-M16A02590006 333136-M16A02590007 333136-M16A02590008 333136-M16A02590009 333136-M16A02590010 333136-M16B08530006 333136-M16B08530011 333136-M16B08530010 333136-M16B08530009 333136-M16B08530008 333136-M16B08530007 333136-M16B08530014 333136-M16B08530005 333136-M16B08530004 333136-M16B08530003…
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-1145-2026
- Initiated
- October 24, 2025
- Posted by FDA
- January 22, 2026
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Quantity
- 14550
- 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-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 |