FDA Device recall Z-1299-2016
system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography…
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography… by Siemens Medical Solutions Usa, citing 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 w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1299-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-26 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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
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.
Identifiers
| code_info | Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1299-2016%22
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