Edan Diagnostics: Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achie

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: 1457 Lot/code info: EDAN Model: iT20 UDI-DI code: 06944413802261 Serial/Lot Numbers: 261350-M17A03030002 261350-M17A03030001 260881-M18407300001 260881-M18407300002 260881-M18407310002 260881-M18407310001 260881-M18703320002 260881-M18703320004 260881-M18703320001 260881-M18703320003 260881-M18800890008 260881-M18800890003 260881-M18800890004 260881-M18800890005 260881-M18800890007 260881-M18800890001 260881-M18800890006 260881-M18800890002 260881-M18800890010 260881-M18810400010 260881-M18810400009 260881-M18810400008 260881-M18810400004 260881-M18810400003 260881-M18810410008 260881-M18810410006 260881-M18810410002 260881-M18810400007 260881-M18810400002 260881-M18810400001 260881-M18810410003 260881-M18810410007 260881-M18810410001 260881-M18810410010 260881-M18810410005 260881-M18810410009 260881-M18810410004 260881-M18810400005 260881-M18810400006 260881-M18901010006 260881-M18901000007 260881-M18901000009 260881-M18901000012 260881-M18901000017 260881-M18901000018 260881-M18901000002 260881-M18901010002 260881-M18901010001 260881-M18901000003 260881-M18901000013 260881-M18901000005 260881-M18901010003 260881-M18901010004 260881-M18901010005 260881-M18901000015 260881-M18901010008 260881-M18901010007 260881-M18901000006 260881-M18901000016 260881-M18901000001 260881-M18901000011 260881-M18901000019 260881-M18901000010 260881-M18901010010 260881-M18901000020 260881-M18901000014 260881-M18901000008 260881-M18901000004 260881-M18901010009 260881-M18905240010 260881-M18905240008 260881-M1890524

UPC codes

06944413802261

Source

Official record: FDA (Device enforcement) ↗

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