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.
What this means for you
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 10764561
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- electrical-leakage
- liquid-ingress
Distribution
Distributed nationwide across the United States.
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