Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number:… — Class II medical device recall Z-1147-2026
Ongoing recall by Edan Diagnostics, reported 2026-01-28, distributed nationwide. As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybers
| Recall number | Z-1147-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edan Diagnostics, San Diego, CA, United States |
| Recall initiated | 2025-10-24 |
| Classified | 2026-01-22 |
| Reported by FDA | 2026-01-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 377 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06944413802179 |
| Lot numbers | 260374-K21800220001, 260374-K21800220002, 260374-M17211490001, 260374-M17211490002, 260374-M17211490003, 260374-M17211490004, 260374-M17211490005, 260374-M18112460001, 260374-M18112460002, 260374-M18401280001, 260374-M18401280002, 260374-M18402820001, 260374-M18407120001, 260374-M18407120002, 260374-M18414750001, 260374-M18414750002, 260374-M18613240001, 260374-M18613240002, 260374-M18A08010001, 260374-M19314330001, 260374-M19314330002, 260374-M19413110001, 260374-M19507180001, 260374-M19507180002, 260374-M19908180001, 260374-M19908180002, 260374-M19908180003, 260374-M19908180004, 260374-M19B01600001, 260374-M19B01600002, 260374-M19B01600003, 260374-M20202590001, 260374-M20202590002, 260374-M20202590003, 260374-M20202590004, 260374-M20202590005, 260374-M20502980001, 260374-M20502980002, 260374-M20502980003, 260374-M20502980004 and 337 more |
| Model numbers | IM20 |
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1147-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.