Siemens Artis X-Ray Systems Recalled for Patient Table Cracks
Siemens is recalling 17 Artis zee and Artis Q interventional X-ray systems because cracks in the patient table mainframe could cause the upper bed to detach, posing a hazard to patients and staff.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural vehicle defect (patient table mainframe cracks) that could lead to mechanical detachment and falling parts, which aligns with the 'Severe' criteria for structural defects and significant injury risk.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 17 Artis zee and Artis Q/Q.zen Interventional Fluoroscopic X-Ray Systems. The recall involves specific material numbers and serial numbers for floor, ceiling, and biplane configurations. These systems are used for diagnostic imaging and interventional procedures such as cardiac and neuro angiography.
The recall is due to a potential defect where the patient table mainframe may develop cracks. This structural issue could cause the upper part of the patient bed to detach mechanically, leading to falling parts. This presents a hazardous situation for both patients and medical personnel.
The affected units were distributed nationwide in the United States, specifically in Alabama, Arkansas, Kansas, Michigan, Minnesota, North Carolina, North Dakota, New York, Ohio, South Carolina, Texas, and Wisconsin. Siemens is the recalling firm responsible for addressing this safety concern.
The recalled product
- Product
- Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 17
Distribution
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