Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 3/3/2020
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
- Recall Number: Z-1346-2020
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.
Siemens Medical Solutions USA, Inc on 1/16/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
64 Worldwide/26 Domestic
US Nationwide and International