CLASS II ONGOING Device recall · Reported 5 Feb 2025 · FDA Enforcement Report
Artis One Angiographic X-Ray System recalled
Siemens Medical Solutions USA is recalling Artis One Angiographic X-Ray System. The recall was initiated on 2 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0922-2025
- FDA event ID
- 96088
- Recalling firm
- Siemens Medical Solutions USA, Malvern
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jan 2025
- FDA classified
- 28 Jan 2025
- Reported
- 5 Feb 2025
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 2 Jan 2025 | Recall initiated by company | |
| 28 Jan 2025 | Classified by FDA | +26 days |
| 5 Feb 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A potential issue with ARTIS One systems 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.
Product as listed by the FDA
ARTIS One Angiographic X-Ray System
Where it was distributed
23 Distributed in the US
Questions about this recall
Why was it recalled?
A potential issue with ARTIS One systems 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.
Which lots are affected?
Model Number 10848600
Where was it sold?
23 Distributed in the US
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Siemens Medical Solutions USA
All 796| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artis icono ceiling recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono biplane recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono floor recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono ceiling recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis pheno recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | PA |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |