Home / Recalls / Siemens Medical Solutions USA, Inc / Z-0936-2019

Z-0936-2019 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-0936-2019 was initiated by Siemens Medical Solutions USA, Inc on Nov 29, 2018 and is designated Class II. 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… The recall status is terminated (terminated May 7, 2020). Affected quantity: 1.

Recall Details

Product Type: Devices
Report Date: Mar 6, 2019
Initiation Date: Nov 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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0936-2019
openFDA file date: Oct 21, 2026
Loaded by RegDataLab: Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.