# FDA recall Z-1558-2022

> **Siemens Medical Solutions USA, Inc** · Class III · device recall initiated 2022-07-12.

## Product

AXIOM Sensis or Sensis Vibe Combo systems as follows:  System	                              Material #  AXIOM Sensis, Combo 64	6623974;  AXIOM Sensis, Hemo LOW	6634633;  AXIOM Sensis, Combo 32	6634641;  AXIOM Sensis, EP 129	6634658;  Sensis	                               10764561;  Sensis Vibe Combo	     11007642;    Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology.

## Reason for recall

The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table),  In the event the mounting position deviates from the default position, the following are possible: Patient touching the Signal Input Box may result in a touch leakage current to the patient; Spillage of liquid entering the Signal Input Box

## Distribution

US Nationwide Distribution  Foreign:   Albania  Algeria  Angola  Argentina  Armenia  Aruba  Australia  Austria  Azerbaijan  Bahrain  Bangladesh  Belgium  Bolivia  Bosnia and Herzegovina  Brunei Darussalam  Bulgaria  Cambodia  Cameroon  Canada  Chile  China  Colombia  Costa Rica  Croatia  Cuba  Cyprus  Czech Republic  Denmark  Ecuador  Egypt  El Salvador  Estonia  Ethiopia  Finland  France  Georgia  Germany  Ghana  Greece  Guatemala  Hong Kong  Hungary  India  Indonesia  Iran  Iraq  Ireland  Israel  Italy  Japan  Jordan  Kazakhstan  Kenya  Kosovo  Kuwait  Latvia  Lebanon  Libya  Luxembourg  Macao  Malaysia  Maldives  Mali  Mauritius  Mexico  Moldova  Montenegro  Morocco  Mozambique  Myanmar  Namibia  Netherlands  New Caledonia  New Zealand  Nigeria  North Korea  Norway  Oman  Pakistan  Palestine, State of  Panama  Paraguay  Peru  Philippines  Poland  Portugal  Qatar  Romania  Rwanda  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  South Korea  Spain  Sri Lanka  Sudan 

## Key facts

- **Recall number:** Z-1558-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-07-12
- **Report date:** 2022-08-24
- **Termination date:** 2024-11-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1558-2022

## Citation

> AI Analytics. FDA recall Z-1558-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1558-2022. Source: US FDA. Licensed CC0.

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