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 due to a cooling system leak that 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential system failure without confirmed adverse health consequences.
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. These dedicated angiography systems are used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography, as well as whole-body radiographic and fluoroscopic procedures.
The recall is due to a leak in the cooling system that allows fluids to potentially seep into the equipment cabinet. Loss of coolant can result in cooling system failure and subsequent system failure. The source notes that this leak can occur sporadically in affected systems.
The affected units were distributed nationwide in the United States. Specific serial numbers for the Artis Q floor units are listed in the agency's structured data. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this issue.
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
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FDA (Devices) · 2017-09-06