FDA-Device2019-11-13Class I
Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723, MMT-523K/723K, MMT-551/751, MMT-554/754, MMT-522/722, MMT-522K/722K, MMT-515/715, MMT-512/712, MMT-511)
Medtronic Inc.
Hazard
There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
Sold states
Distribution was nationwide to consumers and distributors. There was no government/military distribution. Foreign distribution was made to Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Martinique, Namibia, Netherlands, New Caledonia, Norway, Oman, Pakistan, Poland, Reunion, Romania, Russian Federation, Saudi Arabia, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, and United Kingdom.
Affected count
141,519
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723, MMT-523K/723K, MMT-551/751, MMT-554/754, MMT-522/722, MMT-522K/722K, MMT-515/715, MMT-512/712, MMT-511)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0178-2020Don't want to check this manually?
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