Medical device recalls Moderate risk

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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