Siemens AXIOM Sensis Diagnostic Computer Recalled for Dust-Related Failures
Siemens Medical Solutions is recalling 4,095 AXIOM Sensis diagnostic computers because dust accumulation can cause system failures, potentially interrupting clinical treatments.
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: The recall is classified as FDA Class II. The hazard involves potential system failure that could interrupt clinical treatment, but the source text does not report any injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 4,095 units of the AXIOM Sensis diagnostic computer. The device is intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and intracardiac electrophysiology studies. The recall covers units with specific model numbers and serial numbers distributed nationwide.
The recall is due to a risk that an extremely dusty computer can cause problems at system start or, rarely, cause a system failure. If the Sensis system fails, its functions cannot be used. This failure may require clinical treatment to be terminated, restarted, or transferred to a functioning system.
Healthcare facilities should perform a system check prior to performing exams. Users should identify affected units by checking the model and serial numbers listed in the official recall notice.
The recalled product
- Product
- AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 4,095
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model no.: 10764561
- 11007641
- 6623974
- 6634633
- 6634641
Distribution
Distributed nationwide across the United States.
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