FDA Device recall Z-1824-2017
Artis zee, Angiographic x-ray system
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of Artis zee, Angiographic x-ray system by Siemens Medical Solutions Usa, citing software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1824-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-28 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | CA, VA, WI |
Product
Artis zee, Angiographic x-ray system
Reason
Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.
Identifiers
| code_info | Device Model Numbers: 10280959, 10094137, 10094141, Serial numbers: 160449 147208, 153744 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1824-2017%22
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