The Recall Desk
HighFDA (Devices)·Z-2305-2018·Announced 2018-07-04

Siemens Artis Q.zen Biplane Recalled for Display Failure

Siemens Medical Solutions is recalling two Artis Q.zen biplane systems because the display may fail to show images after power save mode, potentially requiring treatment 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 medical device where a display failure could lead to treatment interruption or patient transfer, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling two units of the Artis Q.zen biplane, Material no. 10848355, used for angiography and whole body radiographic/fluoroscopic procedures. The recall is due to a defect where the Large Display may remain black without showing an error message after returning from power save mode, even though X-ray functionality remains active.

This issue does not occur during ongoing procedures. If the display failure 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.

The recalled product

Product
Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Radiography Equipment
Hazard
Affected units
2

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)

  • 123008 123010

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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