Siemens Artis Zeego Angiography Systems Recalled for Tabletop Movement Blockage
Siemens is recalling 459 Artis Zeego angiography systems because the floating tabletop movement may be blocked after a collision sensor activates.
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: The recall involves a medical device with a functional defect that could interfere with procedures, representing a risk-of-harm product where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 459 units of the Artis Zeego angiography system (material 10280959). The recall affects 116 units in the United States and the remainder distributed worldwide. The affected systems are dedicated angiography systems used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography.
The recall is due to a defect where the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. This issue could potentially interfere with the operation of the imaging system during procedures.
The affected units are distributed nationwide in the US across multiple states, including Alabama, Arkansas, Arizona, California, Florida, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia, as well as in foreign countries. Users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the issue.
The recalled product
- Product
- Artis Zeego (material 10280959) - Product Usage: 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. Procedures…
- Manufacturer
- Siemens Medical Solutions USA, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number 160861
Distribution
Part of a larger recall action
This product is one of 4 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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