Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS…

Recall date
January 25, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1215-2017
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
United States distribution

Why it was recalled

Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.

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

What was recalled

PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.

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