Z-0936-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2019
- Initiation Date
- November 29, 2018
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Reason for Recall
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.
Distribution Pattern
The products were distributed to the following US states: NJ.
Code Information
Serial Number 120019