The Recall Desk
HighFDA (Devices)·Z-2312-2018·Announced 2018-07-04

Siemens Artis zee floor MN recalled for display failure

Siemens is recalling Artis zee floor MN systems because the display may fail to show images after power save mode, potentially requiring procedure cancellation.

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 high-risk medical device where a display failure could lead to procedure cancellation or patient transfer, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the Artis zee floor MN, Material no. 10094142, used for angiography and whole body radiographic/fluoroscopic procedures. The recall is due to a defect where the Large Display may not show an image and remains black without an error message after returning from power save mode, even though X-ray capability remains active.

The issue does not occur during ongoing procedures. If the defect occurs, 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 in 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 and ensure patient safety during radiographic procedures.

The recalled product

Product
Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Radiographic Equipment
Hazard
Affected units
1

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)

  • 140406

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 →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc

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Same hazard · display failure

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