CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
Check against the official notice below — it lists the full affected range.
Medtronic is recalling CareLink Personal and CareLink System Therapy Management Software Tools for Diabetes due to a hazard involving incomplete basal rate information transmission. When users upload data from their insulin pump to the software, radio frequency interference from surrounding devices or equipment can disrupt the data transfer, which may result in incomplete basal rate information being transmitted and could lead to inappropriate changes in therapy.
The recall affects approximately 46,461 systems distributed nationwide in the U.S. and internationally in countries including Australia, New Zealand, Canada, countries in the EMEA region, Greater China, India, Japan, Latin America, and South Korea. The affected products are CareLink Personal (model MMT-7333) and CareLink System (model MMT-7350), both using CareLink Uploader (model ACC-7350). The source document does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.
Reason for recall: Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software. Distribution: U.S. Nationwide O.U.S. Worldwide Refer to Associated Documents and uploaded Consignee Lists/Spreadsheets. -Australia New Zealand -Canada -EMEA -Greater China -India -Japan -Latin America -South Korea -Southeast Asia -US Quantity: 46,461 affected systems Lot/code info: CareLinkTM Personal (MMT-7333) using CareLink Uploader (ACC-7350) UDI (GTIN/UPN): 00763000424121 CareLinkTM system (MMT-7350) using CareLink Uploader (ACC-7350) UDI (GTIN/UPN): 00763000424138
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.