Edan Diagnostics: Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professi

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: 13934 Lot/code info: EDAN Model: M3 UDI-DI code: 06944413800618 Serial/Lot Number: 302050-M16200560001 302050-M16200560002 302089-M16203830017 302089-M16203830006 302089-M16203830020 302127-M15B11010006 302127-M16203840001 302127-M16203840002 302127-M16203840003 302127-M16203840004 302127-M16203840005 302127-M16203840006 302127-M16203840007 302127-M16203840008 302127-M16203840009 302127-M16203840010 302127-M16203840011 302127-M16203840012 302127-M16203840013 302127-M16203840014 302089-M16203830019 302089-M16203830018 302089-M16203830016 302089-M16203830015 302089-M16203830014 302089-M16203830013 302089-M16203830012 302089-M16203830011 302089-M16203830010 302089-M16203830008 302089-M16203830007 302089-M16203830005 302089-M16203830004 302089-M16203830009 302050-M16203850007 302089-M16203830003 302050-M16203850001 302089-M16203830002 302089-M16203830001 302050-M16203850010 302050-M16203850009 302050-M16203850008 302050-M16203850002 302050-M16203850006 302050-M16203850005 302050-M16203850004 302050-M16203850003 302050-M16407160008 302050-M16407160007 302050-M16407160006 302050-M16407160005 302050-M16407160004 302050-M16407160003 302050-M16407160002 302050-M16407160001 302050-M16407160009 302050-M16407160010 302127-M16407150005 302127-M16407150004 302127-M16407150003 302127-M16407150002 302127-M16407150001 302089-M16407140001 302089-M16407140002 302089-M16407140004 302089-M16407140005 302089-M16407140006 302089-M16407140007 302089-M16407140008 302089-M16407140009 302089-M16407140010 302089-M1640714000

UPC codes

06944413800618

Source

Official record: FDA (Device enforcement) ↗

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