Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak
Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US because a cooling system leak could cause equipment failure.
What this means for you
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 is classified as FDA Class II. The hazard involves a risk of harm (system failure) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 986 units of the AXIOM Artis zee/zeego and Artis Q/Q.zen x-ray angiographic systems in the United States. These systems are used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography.
The recall is due to a potential leak in the cooling system. If fluids seep into the equipment cabinet, it can result in a loss of coolant, leading to cooling system failure and subsequent system failure. The source notes that this leak can occur sporadically in affected systems.
The affected units are distributed nationwide. The specific serial numbers for the Artis Q.zen biplane systems involved in this recall are listed in the agency's structured data. Siemens is the recalling firm.
The recalled product
- Product
- Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 986
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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FDA (Devices) · 2017-09-06
- HighSiemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak
FDA (Devices) · 2017-09-06