Siemens Artis one X-ray Systems Recalled for Monitor Display Issues
Siemens is recalling Artis one fluoroscopic X-ray systems because the monitor display may blink or show a blue/black screen.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific hazard is a display malfunction (blinking/blue/black screen) which is a functional defect rather than a direct physical injury hazard like fire or shock, fitting the Moderate category for a device with a non-critical operational defect.
Plain-English summary
Siemens Medical Solutions USA, INC is recalling the Artis one floor-mounted interventional fluoroscopic X-ray system. The recall involves 207 units worldwide, with 13 distributed in the United States. The affected systems are equipped with a DP Transceiver below revision 03.
The recall is due to a possibility that the monitor display may experience blinking and/or a blue/black screen. This issue could affect the visibility of the imaging system's display during use.
The affected units were distributed to the states of Arkansas, Missouri, New York, Indiana, Texas, North Carolina, Pennsylvania, Michigan, Louisiana, Washington, California, and Alabama. Specific serial numbers are listed in the recall documentation. Users of these systems should contact Siemens Medical Solutions USA, INC for further instructions regarding the recall.
The recalled product
- Product
- Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray gener
- Manufacturer
- Siemens Medical Solutions USA, INC
- Hazard
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 (10)
- Serial # 82044
- 82105
- 82070
- 82054
- 82040
- 82038
- 82065 82108
- 82010
- 82039
- 82109 82102 82066
Distribution
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