Artis Q systems recallZ-2341-2015 · Siemens Medical Solutions USA, Inc · initiated Jun 29, 2015
Class II Terminated All recalls posted in August 2015
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
The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.
FDA root cause category: Device Design
What the company is doing
A customer safety notice, dated June 29, 2015, was sent to direct accounts to alert them about the issue and that Siemens' service organization will be contacting them to perform the corrective action.
Recall details
- Recall number
- Z-2341-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 29, 2015
- Posted by the FDA
- Aug 5, 2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product code
- OWB
- FDA submissions
- K123529
- Distribution
- US Nationwide
Product description
Artis Q systems; 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Code information (models, lots, serial numbers)
Model Number of device: 10848282 10848281 10848355 10848354 serial numbers: 121006 121013 109016 121011 123008 123003 123011 121014 109011 121004 121018 121036 121012 109015 109009 121019 121010 121015 121016 109007 111000 121020 121009 121056 121057 109021 121008 109020 109027 109010 123010 121041
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.
How recalls are matched to devices · Editorial policy · Report an error on this page