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