Artis Q, and Artis Q.zen ceiling systems recallZ-0972-2015 · Siemens Medical Solutions USA, Inc · initiated Dec 3, 2014
Class II Terminated All recalls posted in January 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
Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure could be terminated in rare cases.
FDA root cause category: Device Design
What the company is doing
Siemens sent an important customer safety information notice, dated December 3, 2014, to all affected customers. The letter identified the product, problem, and action to be taken. The following hardware modifications will be implemented with the corrective action AX042/14/S: 1. A modified cable outlet to provide additional space for the cabling. 2. A modified plastic cover at the cable outlet providing optimal cable guidance in the area of the arc. In general all systems will be checked for existing damage prior to the implementation of this action. For questions regarding this recall call 610-219-6300.
Recall details
- Recall number
- Z-0972-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 3, 2014
- Posted by the FDA
- Jan 14, 2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 50
- Product code
- OWB
- FDA submissions
- K123529
- Distribution
- Nationwide Distribution
Product description
Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is 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 numbers: 10848281; 10848354
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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