Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 3/3/2020
Class II

PRODUCT

COHERENCE Oncologist, Model Nos. 07333680 & 07351898

• Recall Number: Z-1346-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 1/16/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

64 Worldwide/26 Domestic

DISTRIBUTION

US Nationwide and International