Siemens Artis Q X-ray Systems Recalled for Potential Tube Breakdown
Siemens is recalling 19 Artis Q and Artis Q biplane systems because a breakdown of the x-ray tube could result in loss of x-ray imaging during clinical operation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (loss of imaging) where no specific injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 19 units of the Siemens Artis Q and Artis Q biplane systems. These devices are used for interventional fluoroscopic x-ray imaging and are equipped with a flat detector as 40 HDR (large 30x40). The affected units have model numbers 10848280, 10848281, 10848282, and 10848283.
The recall was initiated because there is a possibility that a breakdown of the x-ray tube could occur during clinical operation. If this happens, it could result in a loss of x-ray imaging. The agency has classified this recall as Class II.
The affected units were distributed nationwide in the United States, specifically in the states of Tennessee, Massachusetts, California, Illinois, Ohio, Florida, Utah, Washington, Georgia, Iowa, New York, Missouri, Indiana, and Colorado. No specific instructions for consumers are provided in the source text, as these are medical devices used in clinical settings.
The recalled product
- Product
- Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 19
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 (4)
- model numbers 10848280
- 10848281
- 10848282
- and 10848283.
Distribution
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