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
Reported: January 20, 2021 Initiated: November 12, 2020 #Z-0843-2021
Product Description
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
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.
Details
- Recalling Firm
- Medtronic Inc.
- Units Affected
- 46,461 affected systems
- 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
- Location
- Northridge, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Medtronic Inc.. Units affected: 46,461 affected systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2021. Severity: Moderate. Recall number: Z-0843-2021.
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