Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use…

Recall date
July 26, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2878-2016
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
Nationwide distribution

Why it was recalled

Software patch installation to address several safety issues.

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

What was recalled

Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording

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