Z-0936-2019Class II

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

Name: Z-0936-2019 Sensis Vibe System, Model Number 11007642, with software version VD10B
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-11-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-11-29 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Sensis Vibe System, Model Number 11007642, with software version VD10B on 2018-11-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0936-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-29
Posted: 2019-02-23
Terminated: 2020-05-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Sensis Vibe System, Model Number 11007642, with software version VD10B.
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction letters were sent to customers on 11/29/18.
Quantity in commerce: 1
Distribution: The products were distributed to the following US states: NJ.
Product codes and lots: Serial Number 120019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0936-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0936-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-23

Product code DQK

K150493Class IISensisSiemens Medi Cal Solutions, Inc. / cleared 2015-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)