Siemens Artis X-ray systems cooling malfunction may halt procedures
Siemens Artis interventional X-ray systems may fail to cool the X-ray tube adequately, causing system shutdown and potentially requiring cancellation of clinical imaging procedures. The recall affects 583 units distributed nationwide.
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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard presents a risk of treatment delay or cancellation due to equipment malfunction, meeting the threshold for High severity as a risk-of-harm product without documented injury.
Plain-English summary
Siemens Medical Solutions USA, Inc is recalling Siemens Artis interventional fluoroscopic X-ray systems due to a cooling circuit defect. The cooling circuit may fail to maintain adequate coolant levels, resulting in insufficient cooling of the X-ray tube.
When the X-ray tube overheats, the system displays a "TUBE HOT, have a break" message and becomes unable to operate normally. This may require cancellation of scheduled clinical imaging procedures or necessitate transferring the procedure to an alternative imaging system.
The recall involves 583 units of various Artis models distributed nationwide in the United States, including Artis zee, Artis zeego, Artis Q, and Artis Q.zen models in multiple configurations (floor, ceiling, biplane, and multi-purpose). Each affected unit can be identified by its specific model number and UDI-DI code.
Healthcare facilities should contact Siemens Medical Solutions for guidance regarding inspections or corrective actions.
The recalled product
- Product
- Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Imaging System
- Affected units
- 583
Distribution
Distributed nationwide across the United States.
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