The Recall Desk
HighFDA (Devices)·Z-2306-2018·Announced 2018-07-04

Siemens Artis Q.zeego X-ray System Display Malfunction Recall

Siemens is recalling four Artis Q.zeego X-ray systems because the display may remain black after power save mode, preventing normal operation and 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 where the malfunction prevents normal operation and may require patient transfer, but no injuries or illnesses have been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling four units of the Artis Q.zeego X-ray system (Material no. 10848283) used 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.

This issue does not occur during ongoing procedures. If the malfunction happens, 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 resolve the issue. No injuries or illnesses have been reported in connection with this recall.

The recalled product

Product
Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Radiology Equipment
Hazard
Affected units
4

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)

  • 117012 117006 117018 117040

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 malfunction

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