Recall Z-0922-2025— SIEMENS MEDICAL SOLUTIONS USA, INC
Class II · Ongoing
Class II FDA medical device recall by SIEMENS MEDICAL SOLUTIONS USA, INC, initiated 2025-01-02. It names one FDA 510(k) clearance: K133580. Product: ARTIS One Angiographic X-Ray System. Reason: 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..
- Recalling firm
- SIEMENS MEDICAL SOLUTIONS USA, INC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-02
- Firm location
- Malvern, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.