Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX1...
Reason for Recall / Hazard
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.
Product Description & Identification
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 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
Affected Products
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 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
Additional Source Details
| Field | Value |
|---|---|
| City | San Diego |
| State | CA |
| Event id | 97879 |
| Address 1 | 9833 Pacific Heights Blvd |
| Code info | EDAN Model: iX10 UDI-DI code: 06944413815889 Serial/Lot Numbers: 262541-M24816120001 262541-M24A09820001 262541-M24B06240003 262541-M24B06240002 262541-M24B06240001 262541-M25110410016 262541-M25110420014 262541-M25110420008 262541-M25110420009 262541-M25110420024 262541-M25110420023 262541-M25110420025 262541-M25110420018 262541-M25110410001 262541-M25110410009 262541-M25110410003 262541-M25110410004 262541-M25110410011 262541-M25110410015 262541-M25110410020 262541-M25110410002 262541-M25110410012 262541-M25110410005 262541-M25110410013 262541-M25110410014 262541-M25110410007 262541-M25110410008 262541-M25110410017 262541-M25110410018 262541-M25110410019 262541-M25110410010 262541-M25110420011 262541-M25110410006 262541-M25110420007 262541-M25110420020 262541-M25110420013 262541-M25110420001 262541-M25110420019 262541-M25110420022 262541-M25110420003 262541-M25110420010 262541-M25110420015 262541-M25110420004 262541-M25110420016 262541-M25110420012 262541-M25110420005 262541-M2511042... [TRUNCATED] |
| Postal code | 92121-4707 |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 379 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251024 |
| Initial firm notification | Letter |
| Center classification date | 20260122 |
Overview
- Recalling FirmEdan Diagnostics
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.