Siemens Artis Q and Artis Q biplane systems recallZ-1202-2014 · Siemens Medical Solutions USA, Inc · initiated Dec 5, 2013
Class II Terminated All recalls posted in March 2014
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
There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).
FDA root cause category: Device Design
What the company is doing
Siemens sent an Important Customer Safety Notice letter dated November 22, 2013, to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to discontinue use until the affected product has been successfully replaced by a Siemen's representative.at no cost.
Recall details
- Recall number
- Z-1202-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 5, 2013
- Posted by the FDA
- Mar 27, 2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 19
- Product code
- OWB
- FDA submissions
- K123529
- Distribution
- USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.
Product description
Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
Code information (models, lots, serial numbers)
model numbers 10848280, 10848281, 10848282, and 10848283.
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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