Z-1246-2019 Class II Terminated
FDA device recall Z-1246-2019 was initiated by Siemens Medical Solutions USA, Inc on February 14, 2019 and is designated Class II. Reason for recall: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray … The recall status is terminated (terminated May 1, 2020). Affected quantity: 53 total units distributed in U.S..
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2019
- Initiation Date
- February 14, 2019
- Termination Date
- May 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 total units distributed in U.S.
Product Description
SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Reason for Recall
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
Distribution Pattern
US Nationwide Distribution
Code Information
Serial numbers of all affected models: 122022 100143 100107 83834 83746 83811 66649 122020 83801 122008 122029 83767 83852 100092 83798 100091 100112 100129 100136 83837 122023 83871 100117 100097 100099 122009 83763 83819 83752 83845 83846 83749 83847 100146 83786 83842 83775 100090 83796 83768 83859 100087 83826 83754 83790 122011 83824 100147 83810 83758 100140 100085 83808