Siemens Sensis Vibe Hemo system in combination with the MicroPodTM… — Class II medical device recall Z-2921-2020

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-09-09, distributed nationwide. The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-att

Recall number	`Z-2921-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated	2020-07-24
Classified	2020-08-28
Reported by FDA	2020-09-09
Terminated	2021-11-02
Distributed	Nationwide (US)
Quantity	110 units
Reason classes	device malfunction
Serial numbers	`100064`, `100095`, `100097`, `100103`, `100115`, `100116`, `100117`, `100120`, `100121`, `100163`, `100165`, `100175`, `100176`, `100231`, `100263`, `100279`, `100306`, `100309`, `100346`, `100349`, `100391`, `100408`, `100410`, `100411`, `100412` and 85 more

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.

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2921-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.