FDA Device recall Z-0972-2017
Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for s…
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for s… by Siemens Medical Solutions Usa, citing siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0972-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-08 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
Reason
Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
Identifiers
| code_info | Model # 10848280, 10848281, 10848282, 10848353, 10848354, 10848355 |
|---|
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-0972-2017%22
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