Z-1434-2021Class II

Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis...

Name: Z-1434-2021 Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis...
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-03-04
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-03-04 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM... on 2021-03-04. FDA classified it as Class II and gives the reason as "Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of...". 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-1434-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-04
Posted: 2021-04-19
Terminated: 2024-09-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks and could result in incorrect diagnostic or therapeutic decisions
Root cause tag: software
FDA root cause: Software design
Action: Siemens Healthineers issued Customer Safety Advisory Notice dated 3/4/21 to affected customers via AX074/20/S. Letter states reason for recall, health risk and action to take: Siemens will restrict the Windows Service Permissions to the required level only and the IT security vulnerability of your system will be reduced via Update Instruction AX073/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. .
Quantity in commerce: 99 units
Distribution: US Nationwide distribution.
Product codes and lots: Serial Numbers: As of 8/24/22 (Updated) 10661 11657 14000 14012 14123 14312 14603 14804 14900 14902 15010 15130 15135 15136 15819 15829 15902 15903 15904 15908 15913 15915 15916 15917 15920 15923 15924 15925 15926 15927 15928 18900 18901 100208 100209 100216 100306 100309 102138 102145 102147 102221 102326 103014 103019 103022 103039 103040 103042 103047 103048 103079 103080 103082 103086 103088 103089 103090 103108 103111 103114 103115 103116 103117 103119 103123 103124 103130 103131 103139 103144 103145 103148 103152 103160 103161 103166 103167 103168 103170 103171 103172 103173 103177 103178 103182 103184 103186 103189 103193 103194 103196 103198 103199 103200 103208 103216 123004 123021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1434-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1434-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-19

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)