Recall Z-1154-2026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Edan Diagnostics
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 tim
| Date | Jan 22, 2026 (initiated Oct 24, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 instructe |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113653 | PATIENT MONITOR Edan Instruments, Inc., Feb 6, 2012 |