Edan Diagnostics: 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 continu

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: 377 Lot/code info: EDAN Model: iM20 UDI-DI code: 06944413802179 Serial/Lot Numbers: 260502-M17A03230001 260374-M18401280001 260374-M18401280002 260374-M18407120001 260374-M18407120002 260374-M18613240001 260374-M18613240002 260374-M18A08010001 260374-M20506470001 260374-M20506470003 260374-M20506470005 260374-M20506470002 260374-M20506470004 260374-M18402820001 260374-M20B06690002 260374-M20B06690003 260374-M20B06690001 260374-M20C13130002 260374-M20C13130004 260374-M20C13130001 260374-M20C13130003 260374-M20C13130005 260374-M21108520006 260374-M21108520015 260374-M21108520009 260374-M21108520004 260374-M21108520001 260374-M21108520014 260374-M21108520011 260374-M21108520007 260374-M21108520002 260374-M21108520005 260374-M21108520003 260374-M21108520010 260374-M21108520012 260374-M21108520013 260374-M21108520008 260374-M21608850002 260374-M21616970003 260374-M21608850001 260374-M21608850005 260374-M21608850004 260374-M21616970002 260374-M21608850003 260374-M21616970001 260374-K21800220002 260374-K21800220001 260374-M21A04520003 260374-M21A04520002 260374-M21A04520001 260374-M22105780003 260374-M22105780001 260374-M22105780002 260374-M22301830005 260374-M22301830008 260374-M22301830002 260374-M22301830004 260374-M22301830001 260374-M22301830007 260374-M22301830009 260374-M22301830003 260374-M22301830006 260374-M22301830010 260374-M22405470001 260374-M22405470004 260374-M22405470002 260374-M22405470003 260374-M22405470005 260374-M22507870001 260374-M22511350001 260374-M22511350002 260374-M2251135

UPC codes

06944413802179

Source

Official record: FDA (Device enforcement) ↗

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