Agency classClass IIOur severity:High FDA (Devices)·Z-2314-2018·Announced 2018-07-04

Siemens Artis zeego X-ray System Recalled for Display Failure

Siemens Medical Solutions is recalling 56 Artis zeego systems because the display may fail to show images after power save mode, potentially requiring procedure cancellation.

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 involves a risk-of-harm product where the defect could lead to procedure cancellation or patient transfer, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 56 units of the Artis zeego (Material no. 10280959) for angiography and whole body radiographic/fluoroscopic procedures. The recall is due to a defect where the Large Display may fail to show an image and remain black without an error message after returning from power save mode, even though X-ray capability remains active.

The issue does not occur during an ongoing procedure. If the defect manifests, the system cannot be operated normally, which may necessitate canceling or restarting the treatment or transferring the patient to an alternate system. The affected units were distributed worldwide, including the United States, Puerto Rico, and numerous international locations.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The recall is classified as Class II by the FDA.

The recalled product

Product: Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiology Equipment
Hazard: display-failure
operational-error
Affected units: 56

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 12 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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