Siemens Medical Solutions USA, Inc recalls ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product…

Recall date

January 25, 2017

Source

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

Recall number

Z-1214-2017

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

ONCOR Impression, ONCOR Impression plus, and ONCOR Expression 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.