FDAClass IISeptember 6, 2017

Artis zee/zeego and Artis Q/Q.zen system recall

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…

Why was Artis zee/zeego and Artis Q/Q.zen system recalled?

Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Artis Q.zen biplane- Serial number: 123026 123031 123008 123035 123003 123011 123032 123013 123014 123025 123036 123022 123024 123023 123027 123037 123043 123010 123016 123015

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…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
986 units in USA
Distribution
Nationwide Distribution
Recall date
September 6, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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