Brand Name: EDAN Product Name: Central Monitoring System… — Class II medical device recall Z-1151-2026
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-1151-2026 |
|---|---|
| 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 | 395 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06944413800236, 06944413807983 |
| Lot numbers | 460570-M19710370001, 460570-M19710380001, 460570-M19A06460001, 460570-M19A06460002, 460570-M19A06460003, 460570-M19A06460004, 460570-M19A06460005, 460570-M19A06460006, 460570-M19A06460007, 460570-M19A06460008, 460570-M19A06460009, 460570-M19A06460010, 460570-M19A06460011, 460570-M19A06460012, 460570-M19A06460013, 460570-M19A06460014, 460570-M19A06460015, 460570-M20602690001, 460570-M20602690002, 460570-M20602690003, 460570-M20700020001, 460570-M20700020002, 460570-M20700020003, 460570-M20700020004, 460570-M20700020005, 460570-M20700020006, 460570-M20700020007, 460570-M20700020008, 460570-M20700020009, 460570-M20700020010, 460570-M20700020011, 460570-M20700020012, 460570-M20700020013, 460570-M20807880001, 460570-M20807880002, 460570-M20807880003, 460570-M20807880004, 460570-M20807880005, 460570-M20A08380001, 460570-M20A08380002 and 355 more |
Product
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. 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-1151-2026. 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.