Recall Z-1146-2026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Edan Diagnostics
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which 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 abn
| 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 | 342 |
| 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
| K160981 | Patient Monitor Edan Instruments, Inc., Dec 22, 2016 |