The Recall Desk
HighFDA (Devices)·Z-2307-2018·Announced 2018-07-04

Siemens Artis Q.zen floor recall for display failure after power save

Siemens is recalling Artis Q.zen floor units because the display may fail to show images after power save mode, potentially requiring procedure cancellation or patient transfer.

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 risk-of-harm product (medical device) where the defect could lead to procedure cancellation or patient transfer, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling one unit of the Artis Q.zen floor, Material no. 10848353, 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 functionality remains active.

This issue does not occur during an ongoing procedure. If the problem 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 unit was 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. No specific instructions for end-users are provided in the source text, as the product is a professional medical device.

The recalled product

Product
Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Radiology 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)

  • 105007

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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