Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number:… — Class II medical device recall Z-1146-2026
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-1146-2026 |
|---|---|
| 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 | 342 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06944413801707, 06944413802155, 06944413802162 |
| Lot numbers | 002338-K22100150001, 002338-K22100150002, 002338-K22100150003, 002338-K22100150004, 002338-M23226990001, 002338-M23226990002, 002338-M23226990003, 002338-M23226990004, 002338-M23812870001, 002338-M23C15870001, 002338-M24A12130001, 002338-M25705810001, 002338-M25705810002, 002338-M25705810003, 002338-M25705810004, 002338-M25705810005, 002338-M25705810006, 002338-M25705810007, 002338-M25705810008, 002338-M25705810009, 002338-M25705810010, 002338-M25705810011, 002338-M25705810012, 002338-M25705810013, 002338-M25705810014, 002338-M25705810015, 002338-M25705810016, 002338-M25705810017, 002338-M25705810018, 002338-M25705810019, 002338-M25705810020, 002338-M25705810021, 002338-M25705810022, 002338-M25705810023, 002338-M25705810024, 002338-M25705810025, 002338-M25705810026, 002338-M25705810027, 002338-M25705810028, 002338-M25705810029 and 302 more |
Product
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 abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). 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-1146-2026. 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.