FDA-Device2020-03-25Class II
Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
Sold states
Worldwide distribution. US Nationwide including Puerto Rico, Argentina, Brazil, Colombia, Trinidad and Tobago, Venezuela, Dominican Republic, Bahamas, Peru, Bermuda, Barbados, Ecuador, Cayman Islands, Curacao, Guatemala, Honduras, Panama, El Salvador, Costa Rica, Bolivia, Chile, Uruguay, Paraguay, Mexico, Jamaica, Japan, Belgium, Greece, Germany, Switzerland, United Kingdom, Spain, Italy, Luxembourg, Poland, Austria, Suriname, Netherlands, Aruba, Hungary, Liechtenstein, Sweden, Czech Republic, Ireland, France, French Polynesia, New Caledonia, Guadeloupe, Reunion, Mauritius, Kenya, South Africa, Uganda, Namibia, Finland, Norway, Portugal, Iceland, Denmark, Faroe Islands, Greenland, Macedonia, Iraq, Pakistan, Sudan, Jordan, Morocco, Belarus, Lebanon, Sri Lanka, Kazakhstan, Bulgaria, Egypt, Turkey, Libya, Serbia, Tunisia, Cyprus, Oman, Slovenia, Algeria, Malta, Croatia, Saudi Arabia, Syria, Kuwait, Latvia, Ukraine, Andorra, Burkina Faso, Nepal, Mayotte, French Guiana, Martinique, Bosnia And Herzegovina, Qatar, United Arab Emirates, Georgia, Yemen, Slovakia, Iran, Canada, Lithuania, United States, Cote D'Ivoire, Nicaragua, Zimbabwe, Azerbaijan, Albania, Ghana, India, Israel, Guam, American Samoa, Korea, Armenia, Mozambique, Nigeria, Bangladesh, Australia, Taiwan, Cambodia, Hong Kong, Malaysia, Viet Nam, Singapore, New Zealand, Indonesia, Philippines, Angola, Rwanda, Northern Mariana Islands, Senegal, Cameroon, Botswana,Russian Federation, Montenegro, China, Turkmenistan, St. Maarten, Tanzania, Kyrgyzstan, Netherlands Antilles, Cuba, Romania, Mongolia, Kosovo, Tajikistan, Benin, Ethiopia, Moldova, Afghanistan, Democratic Republic of Congo, and Thailand
Affected count
5,540 devices
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1525-2020Don't want to check this manually?
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