Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 4/15/2020
Class II
PRODUCT
ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
- Recall Number: Z-1677-2020
REASON
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc on 2/18/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1012
DISTRIBUTION
US Nationwide and International