Edan Diagnostics: Brand Name: EDAN Product Name: Vital Signs Monitor
Recall reason: 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.. Recalled by Edan Diagnostics. 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.. Classification (Class II — potential health risk). Affected lots/dates: EDAN Model: iM3 UDI-DI code: 06944413808812 Serial/Lot Numbers: 261436-M19B06650005 261436-M19B06650003 261436-M19B06660. Contact the manufacturer or the retailer where you purchased this device to arrange for a free correction, repair, or replacement.
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