FDA Device recall Z-0200-2022
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application s…
- FDA Device
- Class II
- ongoing
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application s… by Siemens Medical Solutions Usa, citing software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0200-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-24 |
| Published | 2021-11-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815
Reason
Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient
Identifiers
| code_info | Artis zeego systems with Artis patient table and AppSW VD20C/VD20N |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0200-2022%22
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