Artis systems with large display from Siemens Medical Solutions USA — Class II medical device recall Z-0481-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-12-30, distributed in AL, CA, FL, IL, MA, MI, ND, NJ…. Due to improper soldering in a limited number of large display bypass module components of a specific producti
| Recall number | Z-0481-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2015-10-30 |
| Classified | 2015-12-24 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2017-03-28 |
| Distributed | AL, CA, FL, IL, MA, MI, ND, NJ, OH, TN, TX, WI |
| Quantity | 17 |
| Serial numbers | 103030, 109104, 109105, 109107, 121085, 121088, 121096, 123026, 123031, 125004, 131005, 137551, 147909, 147910, 147912, 147919, 147921 |
| Model numbers | 10094135, 10094137, 10094141, 10848280, 10848281, 10848282, 10848355 |
Product
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0481-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.