Z-2688-2017Class II

Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161...

Name: Z-2688-2017 Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161...
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-05-16
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-05-16 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer on 2017-05-16. FDA classified it as Class II and gives the reason as "Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient being combined into...". 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-2688-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-16
Posted: 2017-07-06
Terminated: 2018-08-22
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient being combined into one report. --- The error causes information from two examinations to be combined into one report. This does not result in a hazardous situation; however, if the erroneous report has been used for treatment or diagnosis, this can potentially result in an incorrect treatment or diagnosis.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Customer Safety Advisory Notice dated May 16, 2017, was mailed to all users on May 16, 2017. The letter informs customers of the software issue and potential impact. Siemens Medical Solutions will contact users to make arrangements to update the system with updated software to correct the issue. For further questions, please call (610) 448-6461.
Quantity in commerce: US: 13 units
Distribution: US Distribution to the states of : IN, MI, IA
Product codes and lots: Software Version VD10B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2688-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2688-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-06

Product code DQK

K020440Class IINewcorSiemens Medical Systems, Inc. / cleared 2002-12-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)