Z-1282-2019 Class II Terminated
FDA device recall Z-1282-2019 was initiated by Medtronic Inc. on Jul 4, 2018 and is designated Class II. Reason for recall: The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could… The recall status is terminated (terminated Jun 6, 2022). Affected quantity: Approximately 9,328 registered users.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2019
- Initiation Date
- Jul 4, 2018
- Termination Date
- Jun 6, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Approximately 9,328 registered users
Product Description
Reason for Recall
Distribution Pattern
Distribution was only made OUS. Countries involved are: Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Turkey, and South Africa.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1282-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026