Recall – Hemodynamic system software error results in system crash

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)

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.