system — Class II medical device recall Z-1299-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-04-06, distributed nationwide. In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to b
| Recall number | Z-1299-2016 |
|---|---|
| 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 | 2016-02-26 |
| Classified | 2016-03-31 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2017-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 552 units |
| Reason classes | device malfunction |
| Model numbers | 10094135, 10094137, 10094139, 10094141, 10280959 |
Product
system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Reason for recall
In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the X-ray tube) can result in the failure of a module in the high-voltage generator.
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-1299-2016. 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.