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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1524-2020

Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

Publicado el 25 de marzo de 2020 · Inicio del retiro: 30 de enero de 2020

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Distribuidor
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
Lote
Product Number 2090; All Serial Numbers; Known Model Numbers: a. Model Number 2090, GTIN (Lot Numbers): 00721902546341 (PKK002840R), 00721902246234 (PKK012608R), 00721902246234 (PKK013358R), 00721902569517 (PKK017436R), 00613994580955 (PKK204009R), 00643169537828 (PKK001072R), 00613994175397 (PKK001076R), 00613994175397 (PKK001135R), 00613994175397 (PKK001172R), 00613994175120 (PKK001321R), 00613994175106 (PKK001322R), 00721902246234 (PKK001324R), 00721902246227 (PKK001327R), 00613994175212 (PKK001328R), 00613994175106 (PKK001331R), 00643169537828 (PKK001332R), 00721902246234 (PKK001335R), 00613994175144 (PKK001348R), 00721902246227 (PKK001352R), 00613994175076 (PKK001358R), 00613994581075 (PKK001359R), 00721902246234 (PKK001361R), 00643169537828 (PKK001362R), 00613994175397 (PKK001364R), 00613994581204 (PKK001367R), 00613994175267 (PKK001373R), 00613994175397 (PKK001376R), 00613994175120 (PKK001382R), 00613994175397 (PKK001386R), 00613994175083 (PKK001387R), 00643169537828 (PKK001390R), 00613994175397 (PKK001395R), 00613994581235 (PKK001398R), 00613994175106 (PKK001400R), 00721902246234 (PKK001401R), 00613994175212 (PKK001403R), 00613994175106 (PKK001407R), 00613994136534 (PKK001409R), 00613994175120 (PKK001410R), 00613994581235 (PKK001411R), 00613994581228 (PKK001420R), 00613994136527 (PKK001421R), 00613994136527 (PKK001422R), 00613994175120 (PKK001425R), 00613994175182 (PKK001431R), 00643169440166 (PKK001433R), 00613994175076 (PKK001437R), 00613994175083 (PKK001444R), 00613994175076 (PKK001448R), 00613994581228 (PKK001454R), 00613994175380 (PKK001459R), 00613994175380 (PKK001460R), 00613994175090 (PKK001473R), 00613994175083 (PKK001474R), 00613994175106 (PKK001476R), 00613994136527 (PKK001480R), 00613994581075 (PKK001484R), 00613994175212 (PKK001485R), 00613994175120 (PKK001487R), 00613994175106 (PKK001488R), 00613994175397 (PKK001489R), 00613994175212 (PKK001490R), 00613994175106 (PKK001494R), 00721902246241 (PKK001496R), 00613994175076 (PKK001497R), 00721902246227 (PKK001503R), 00643169537828 (PKK001506R), 00613994175083 (PKK001510R), 00613994581235 (PKK001511R), 00721902246241 (PKK001519R), 00613994581013 (PKK001520R), 00613994175120 (PKK001524R), 00613994175212 (PKK001525R), 00613994581235 (PKK001531R), 00721902246234 (PKK001532R), 00613994175106 (PKK001533R), 00721902246234 (PKK001539R), 00721902246234 (PKK001541R), 00613994136527 (PKK001542R), 00613994581594 (PKK001550R), 00721902246234 (PKK001551R), 00613994581013 (PKK001555R), 00613994175397 (PKK001556R), 00613994581075 (PKK001561R), 00721902246234 (PKK001562R), 00613994136527 (PKK001563R), 00613994175120 (PKK001568R), 00721902246234 (PKK001569R), 00613994581174 (PKK001582R), 00613994175212 (PKK001591R), 00613994136527 (PKK001596R), 00721902246234 (PKK001601R), 00721902246234 (PKK001602R), 00613994175120 (PKK001603R), 00613994175120 (PKK001607R), 00613994581174 (PKK001609R), 00721902246241 (PKK001611R), 00613994136534 (PKK001612R), 00613994581235 (PKK001613R), 00613994175083 (PKK001627R), 00643169537828 (PKK001631R), 00613994175083 (PKK001632R), 00613994581174 (PKK001636R), 00613994175106 (PKK001640R), 00613994175212 (PKK001646R), 00613994175106 (PKK001647R), 00613994175120 (PKK001648R), 00721902246241 (PKK001649R), 00613994581013 (PKK001653R), 00613994581075 (PKK001660R), 00721902246234 (PKK001669R), 00613994175106 (PKK001670R), 00613994175083 (PKK001672R), 00721902246234 (PKK001673R), 00613994175120 (PKK001679R), 00721902246234 (PKK001680R), 00613994175397 (PKK001681R), 00613994175106 (PKK001684R), 00613994581594 (PKK001696R), 00613994175120 (PKK001699R), 00613994136534 (PKK001705R), 00613994580863 (PKK001707R), 00643169537828 (PKK001716R), 00613994580894 (PKK001719R), 00613994175106 (PKK001721R), 0061399417539
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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