Z-0586-2017 Class II Terminated
FDA device recall Z-0586-2017 was initiated by Roche Diabetes Care, Inc. on Sep 14, 2016 and is designated Class II. Reason for recall: Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming… The recall status is terminated (terminated Jun 6, 2017). Affected quantity: 7,909 downloads of iOS version 1.2.0 of the Accu-Chek Connect Diabetes Management App in the US and 8,775 downloads…
Recall Details
- Product Type
- Devices
- Report Date
- Nov 23, 2016
- Initiation Date
- Sep 14, 2016
- Termination Date
- Jun 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,909 downloads of iOS version 1.2.0 of the Accu-Chek Connect Diabetes Management App in the US and 8,775 downloads Internationally
Product Description
Reason for Recall
Distribution Pattern
US Distribution to the states of : Alabama, Arizona, Arkansas, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin Foreign: None provided
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-0586-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026