Device product
Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).
Z-0177-2020
Product summary
- Firm
- Medtronic Inc.
- Event
- Event 82078
- Status
- Terminated
- Classification
- Class I
- Quantity
- 90,213
- Official record key
device-enforcement:Z-0177-2020
Official wording
Reason: There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
Code information: All serial numbers
Distribution pattern: 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.
Derived failure modes
-
Unknown
There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.