Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number:...
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: 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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | San Diego |
| State | CA |
| Event id | 97879 |
| Address 1 | 9833 Pacific Heights Blvd |
| Code info | EDAN Model: MFM-CNS UDI-DI code: 06944413800236 Serial/Lot Numbers: 460793-M18C12290001 460793-M19109170001 460793-M19200240001 460793-M19411950001 460793-M19804210001 460793-M19912750001 460793-M19B07530001 460793-M20809190001 460793-M20913190002 460793-M20913190001 460793-M20B19040001 460793-M21600070001 460793-M21603510001 460793-M24702870002 460793-M24702870001 460793-M25203640001 460793-M25314460001 460793-M25314460002 460793-M25610650001 460793-M25610650003 460793-M25610650002 EDAN Model: MFM-CNS Lite UDI-DI code: 06944413807983 Serial/Lot Numbers: 460570-M19710380001 460570-M19710370001 460570-M19A06460005 460570-M19A06460006 460570-M19A06460007 460570-M19A06460015 460570-M19A06460008 460570-M19A06460009 460570-M19A06460001 460570-M19A06460011 460570-M19A06460003 460570-M19A06460004 460570-M19A06460010 460570-M19A06460002 460570-M19A06460012 460570-M19A06460013 460570-M19A06460014 460570-M20602690001 460570-M20602690003 460570-M20602690002 460570-M20700020009 460570-M2070002000... [TRUNCATED] |
| Postal code | 92121-4707 |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 395 |
| 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.