ARTIS Q, Interventional Fluroscopic x-ray system recallZ-1534-2017 · Siemens Medical Solutions USA, Inc · initiated Feb 22, 2017
Class II Terminated All recalls posted in March 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.
FDA root cause category: Other
What the company is doing
A Customer Safety Advisory Notice (CSAN) was mailed on 02/22/2017 to customers affected by the issue on 02/22/2017 to inform them of the corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the impact on system operation and the potential risk to patients. It also informed users of the actions being taken and how they will be implemented.
Recall details
- Recall number
- Z-1534-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 22, 2017
- Posted by the FDA
- Mar 19, 2017
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 264 distributed worldwide (112 in the U.S.)
- Product code
- OWB
- FDA submissions
- K123529
- Distribution
- Distributed throughout the United States.
Product description
ARTIS Q, Interventional Fluroscopic x-ray system
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Model # 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355 Serial # 109033 117012 121061 109080 109074 121006 121013 121040 105007 111005 109016 121062 111002 121082 121011 121039 123008 109066 109067 109068 121053 121054 117001 117023 123003 123011 109084 121014 121051 109011 121004 117021 121018 121036 123013 123014 117029 117006 121012 121049 103013 109015 121019 109057 121010 117034 103008 109038 109040 109034 117020 109029 111003 121015 109064 109009 117018 117030 109058 121016 109050 109076 117026 123022 109007 103001 111000 109071 109072 109075 121020 109090 109041 109039 109060 121047 123023 123024 117024 109088 121027 121069 109032 121009 121056 121057 109021 121034 121008 109048 109020 109036 109043 121058 109047 109031 109027 109028 109010 121071 109069 117014 123010 117009 121023 123015 123016 121041 109044 121037 121046 121072
Other devices under the same FDA submission
7 devices cleared under K123529 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Artis zeego 10848283Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system5 recalls1 death7 reports
- Artis Q ceiling 10848281Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls1 death49 reports
- Artis Q biplane 10848282Siemens Healthcare GmbH · System, x-ray, fluoroscopic, image-intensified4 recalls1 death46 reports
- Artis Q floor 10848280Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls18 reports
- Artis Q.zen ceiling 10848354Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls10 reports
- Artis Q.zen floor 10848353Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls5 reports
- Artis Q.zen biplane 10848355Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system4 recalls5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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