Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Sensis Vibe System, Model Number 11007642, with software version VD10B.

FDA Recall Z-0936-2019 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeDQK
Date Initiated2018-11-29
Date Terminated2020-05-07
Product Quantity1

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.

Firm Action

Urgent Medical Device Correction letters were sent to customers on 11/29/18.

Root Cause

Software design

Distribution Pattern

The products were distributed to the following US states: NJ.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑