Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-1558-2022·Announced 2022-08-24

Sensis Signal Input Box recall for patient electrical leakage hazard with improper mounting

Siemens recalls 399 units of AXIOM Sensis systems due to risk of patient electrical shock if the Signal Input Box mounting deviates from its default position.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The hazard—patient electrical leakage current if mounting deviates from default position—is conditional and theoretical. Class III recalls typically score 1 or 2; this rates as Moderate (2) due to potential patient electrical harm, despite no incidents reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 399 units of AXIOM Sensis and Sensis Vibe Combo systems in the United States, with additional units distributed internationally. These systems are diagnostic recording devices used to support hemodynamic catheterizations and electrophysiology studies in cardiac and interventional radiology.

The Signal Input Box component has milled hooks on its bottom designed to allow mounting on an accessory rail (such as at a patient table). If the mounting position deviates from the manufacturer's default position, two hazards are possible: a patient may experience touch leakage current from contact with the box, or liquid may spill into the device, potentially affecting its function.

The recall affects specific serial numbers within the Sensis (UDI-DI: 04056869010137) and Sensis Vibe Combo (UDI-DI: 04056869010205) product lines. Healthcare facilities should verify whether they have affected units using the serial numbers listed in the official FDA recall notice at accessdata.fda.gov.

The recalled product

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…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Cardiac Diagnostic Recording System
Hazard: electrical-leakage
liquid-ingress
Affected units: 399

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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