Artis systems with large display from Siemens Medical… recallZ-0481-2016 · Siemens Medical Solutions USA, Inc · initiated Oct 30, 2015
Class II Terminated All recalls posted in December 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
Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.
FDA root cause category: Software design
What the company is doing
Siemens sent an Important Customer Safety Notice dated October 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The issue will be remedied with a hardware update AX025/15/S. The affected bypass module hardware will be exchanged with unaffected production lots to eliminate the problem. For further questions call: (610) 219-6300.
Recall details
- Recall number
- Z-0481-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 30, 2015
- Posted by the FDA
- Dec 24, 2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 17
- Product code
- OWB
- FDA submissions
- K073290, K123529
- Distribution
- US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI.
Product description
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
Code information (models, lots, serial numbers)
Model numbers 10094135, 10094137, 10094141, 10848280, 10848281, 10848282, 10848355. Serial Numbers 123026, 147909, 123031, 103030, 147912, 147910, 147921, 147919, 131005, 121096, 125004, 137551, 121088, 109104, 109105, 109107, and 121085.
Other devices under the same FDA submission
7 devices cleared under K073290, 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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