The Recall Desk
SevereFDA (Devices)·Z-2367-2019·Announced 2019-09-04

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.

What this means for you

Illness, injury, or structural failure has been reported. 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 10
Affected units
17

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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