Edan Diagnostics: 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 soft

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.

Details from the source

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. Distribution: Worldwide - 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. Quantity: 395 Lot/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-M20700020002 460570-M20700020011 460570-M20700020012 460570-M20700020005 460570-M20700020007 460570-M20700020013 460570-M20700020008 460570-M20700020003 460570-M20700020004 460570-M20700020001 460570-M20700020010 460570-M20700020006 460570-M20807880003 460570-M20807880005 460570-M20807880001 460570-M20807880002 460570-M20807880004 460570-M20A08380001 460570-M20A08380004 460570-M20A08380005 460570-M20A08380002 460570-M20A08380003 460570-M20C16310008 460570-M20C16310009 460570-M20C16310010 460570-M20C16310004

UPC codes

06944413800236, 06944413807983

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.