Edan Diagnostics: Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a

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: 354 Lot/code info: EDAN Model: M3B UDI-DI code: 06944413800625 Serial/Lot Numbers: 302135-M16304900001 302135-M16304900002 261184-K17400190004 261184-K17400190001 261184-K17400190006 261184-K17400190002 261184-K17400190005 261184-K17400190003 261184-M17A03040001 261184-M18502370001 360126-M18810390001 360126-M18A08360001 360126-M18B13740001 360126-M19302070001 360126-M19302070002 360126-M19302070004 360126-M19302070003 360126-M20310110001 360126-M20310110002 360126-M20507230004 360126-M20507230003 360126-M20507230002 360126-M20507230001 360126-M20507230010 360126-M20507230007 360126-M20507230006 360126-M20507230008 360126-M20507230009 360126-M20507230005 360126-M23226940004 360126-M23226940005 360126-M23226940003 360126-M23226940001 360126-M23226940002 360126-M24511420002 360126-M24511420001 360126-M24716380001 360126-M24716380002 360126-M24716380003 360126-M24716380004 360126-M24716380005 302135-M16403060001 302135-M16403060002 302135-M16403060003 302135-M16403060004 302135-M16901880001 302135-M16901880002 302135-M16901880003 360126-M19805440001 360126-M19805440002 360126-M19805440003 360126-M19805440004 360126-M20A13020002 360126-M20A13020001 360126-M20C18100001 360126-M21113380001 360126-M21404350001 360126-K23100140005 360126-K23100140004 360126-K23100140006 360126-K23100140001 360126-K23100140002 360126-K23100140003 360126-K23200180002 360126-K23200180003 360126-K23200180004 360126-M23222190005 360126-M23222190004 360126-M23222190002 360126-K23200180005 360126-K23200180001 360126-M23222190

UPC codes

06944413800625

Source

Official record: FDA (Device enforcement) ↗

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