Agency classClass IIOur severity:High FDA (Devices)·Z-1339-2019·Announced 2019-05-22

Siemens Artis Zee Angiography Systems Recalled for Tabletop Movement Blockage

Siemens is recalling 459 Artis Zee angiography systems because the floating tabletop movement may be blocked after a collision sensor is activated.

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 is classified as FDA Class II, and the hazard involves a mechanical failure in a medical device that could impede patient care or cause injury, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 459 units of the AXIOM Artis zee and Q/Q.zen angiography systems, including 116 units in the United States. These systems are used for diagnostic imaging and interventional procedures such as cardiac and neuro 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 affects the specific serial numbers listed in the recall notice.

The affected units were distributed worldwide, including nationwide distribution in the United States across 32 states. Siemens is the recalling firm for this Class II recall.

The recalled product

Product: Artis Zee (material # 10094135, 10094137, 10094141) - 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…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Angiography System
Hazard: mechanical-failure
movement-blockage

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

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.

See all 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

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Same hazard · mechanical failure