FDA Device recall Z-2240-2024
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includ…
- FDA Device
- Class II
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includ… by Siemens Ag Siemens Healthcare, citing A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2240-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-26 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Ag Siemens Healthcare |
| Distribution | US |
Product
ARTIS 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
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
Identifiers
| code_info | ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2240-2024%22
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