Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
- Recall date
- May 15, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2020-2025
- FDA classification
- Class II
- Brand / firm
- Siemens Medical Solutions USA, Inc
- Sold / distributed
- Worldwide.
Why it was recalled
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
interventional fluoroscopic x-ray system
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