Z-2921-2020Class II

Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative...

Name: Z-2921-2020 Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative...
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-07-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-07-24 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization... on 2020-07-24. FDA classified it as Class II and gives the reason as "The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2921-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-24
Posted: 2020-08-28
Terminated: 2021-11-02
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and all vital signs are lost
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Siemens issued Customer Safety Advisory Notice distributed dated July 24 2020 to customers via AX048/20/S. Letter states reason for recall, health risk and action to take: If the connector linking the EtCO2 module to the HemoBox should become damaged or break, the operator shall not attempt to fix the connector or re-connect the cable to the HemoBox. Only Siemens Customer Service representative or a service provider authorized by Siemens Healthineers may resolve the issue. Siemens strongly recommends that you do not attempt to fix the connector or re-connect the cable to the HemoBox until the problem has been corrected by a service engineer. Siemens is currently developing a solution to eliminate the root cause of this problem. Our service organization will contact you when a solution has been initiated to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436. Following the correction, the cause will be eliminated, and any recurrence of this potential fault is prevented.
Quantity in commerce: 110 units US
Distribution: US Nationwide distribution.
Product codes and lots: Serial Numbers: 100413 100414 100417 101016 101017 101019 101020 101022 101029 101031 101036 100263 100416 102008 101083 102138 102019 102021 102025 102029 102145 102147 100346 100349 102199 100095 100097 100103 100115 100116 100117 100120 100121 102158 102167 102168 102172 102272 102068 102069 102078 102080 102093 102221 100163 100165 100306 100309 101056 101099 101100 101101 101060 101068 101069 101070 101071 101072 100064 100422 100279 100408 100410 100411 100412 101043 102162 102285 102286 102183 100231 102060 102062 102049 102051 102057 102030 102031 101008 101093 101094 100175 100176 102226 101097 102269 102273 102276 102278 102279 102283 102193 102155 102157 102174 102182 102181 102214 102216 102219 102222 102237 102242 100391 101089 101095 102274 101018 102143 102091 9/01/20 Expanded S/N: 11007641 11007641 11007641 ***9/28/20 Expanded S/N*** 103053 103040 103042 103008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2921-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2921-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-09	2020-08-28

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)