Siemens Artis One Angiography System Recalled for Monitor Failure
Siemens Medical Solutions is recalling one Artis One angiography system because the monitor may fail and require a power cycle to resume operation.
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, but the source text describes a sporadic, non-systematic monitor failure that requires a power cycle to fix, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling one unit of the Artis One angiography system. The system is used for diagnostic interventional procedures, including cardiac, neuro, and general angiography, as well as whole-body radiographic and fluoroscopic procedures.
The recall is due to a sporadic issue where the monitor may fail and requires a power cycle (shutdown and then power on) to resume operation. The problem is not systematic and affects single units. The specific unit involved is Model Number 10848600, serial number 82010.
The distribution pattern is listed as nationwide distribution to Michigan only. No injuries or illnesses have been reported in the source text.
The recalled product
- Product
- Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 1
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 (2)
- Model Number 10848600
- serial number 82010
Distribution
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