Siemens Medical Solutions USA product recalled over injury risk

Recall date

July 3, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Siemens Medical Solutions USA, Inc recalls Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting…

Recall number

Z-2441-2024

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.

Why it was recalled

If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations. Model: 11007641