Siemens Medical Solutions USA, Inc recalls COHERENCE Oncologist, Model Nos. 07333680 & 07351898

Recall date

January 16, 2020

Source

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

Recall number

Z-1346-2020

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.

Why it was recalled

A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.

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

What was recalled

COHERENCE Oncologist, Model Nos. 07333680 & 07351898