Z-1173-2021Class II

Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and...

Name: Z-1173-2021 Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and...
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-01-27
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-01-27 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic... on 2021-01-27. FDA classified it as Class II and gives the reason as "System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system". 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-1173-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-27
Posted: 2021-03-04
Terminated: 2021-10-25
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued Urgent Medical Device Correction via Customer Safety Advisory Notice AX010/21/S dated 1/27/21distributed to all affected customers. Additionally, a solution to eliminate the root cause of this problem is being distributed via Update Instruction AX009/21/S to all affected customers. Letter states reason for recall, health risk and action to take: The freeze is a total lock-up of the system and requires a power cycle of the PC to recover. Please make sure that an alternative system can be used to continue treatment in such cases.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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. 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: 37 US
Distribution: US Nationwide distribution in the states of AK, AR, CA, GU, IA, IL, MI, MO, NC, NE, OR, PA, PA, PR, SD, TN, TX, WA.
Product codes and lots: Software version VD12 and equipped with HP Flex Pro-C PC Serial Numbers: 10704 18900 18901 103008 103014 103019 103022 103039 103040 103042 103047 103048 103053 103079 103080 103082 103086 103088 103089 103090 103115 103116 103117 103119 103123 103124 103130 103131 103137 103144 103145 103148 103152 103160 103170 103171 123004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1173-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1173-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-10	2021-03-04

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)