Siemens Artis one Fluoroscopic X-Ray System Recalled for Table Defect
Siemens is recalling 16 Artis one fluoroscopic x-ray systems because a missing or incorrect snap ring could cause the tabletop to slide to the floor.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a structural defect in a medical device that could cause the table to collapse, posing a risk of injury to patients or staff, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 16 Artis one fluoroscopic x-ray systems and patient tables. The recall is due to a defect where a snap ring may be missing or incorrectly installed. This issue could cause a bolt to slide out of its base, resulting in the tabletop carriage sliding to the floor.
The affected units were distributed in the United States to the states of Alabama, Arkansas, California, Florida, Indiana, Louisiana, Michigan, Missouri, North Carolina, New York, Pennsylvania, Texas, and Washington. The specific serial numbers for the recalled units are 82044, 82105, 82070, 82213, 82054, 82040, 82038, 82205, 82065, 82267, 82108, 82010, 82039, 82109, 82102, and 82066.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 16
Distribution
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