Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 3/6/2019
Class II:
PRODUCT
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Recall Number: Z-0936-2019
REASON
A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc on 11/29/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
New Jersey (US)