Siemens Artis Q X-Ray Systems Recalled for Temperature Control Defect
Siemens is recalling 429 Artis Q Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool down outside its designed working range.
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, and the source text does not report any hospitalizations, injuries, or deaths. The hazard is a functional defect (temperature control) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 429 units of the Artis Q Interventional Fluoroscopic X-Ray System, including model numbers 10848280, 10848281, 10848282, 10848283, 10848354, and 10848355. The affected units were distributed nationwide in the United States.
The recall is due to an incorrectly configured temperature control unit. This defect may cause the temperature of the detector to fall out of its designed working range, specifically by cooling down. This unintentional system behavior may occur while the unit is powered down for long periods, such as at night.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 429
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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