ARTIS One Angiographic X-Ray System
Reported: February 5, 2025 Initiated: January 2, 2025 #Z-0922-2025
Product Description
ARTIS One Angiographic X-Ray System
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.
Details
- Recalling Firm
- SIEMENS MEDICAL SOLUTIONS USA, INC
- Units Affected
- 1140
- Distribution
- 23 Distributed in the US
- Location
- Malvern
Frequently Asked Questions
What product was recalled? ▼
ARTIS One Angiographic X-Ray System. Recalled by SIEMENS MEDICAL SOLUTIONS USA, INC. Units affected: 1140.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2025. Severity: Moderate. Recall number: Z-0922-2025.
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