High FDA (Devices)·Z-2311-2018·Announced 2018-07-04

Siemens Artis zee floor recall due to display failure

Siemens is recalling 14 Artis zee floor systems because the display may fail to show images after power save mode, potentially requiring treatment 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 risk-of-harm product where the display failure may require treatment cancellation or patient transfer, but no injuries or illnesses have been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 14 Artis zee floor systems (Material no. 10094135) used for angiography and whole body radiographic/fluoroscopic procedures. The recall covers units distributed worldwide, including the United States, Puerto Rico, and numerous international locations.

The recall is issued because the Large Display may fail to show an image and remain black without displaying 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 problem arises, the system cannot be operated normally, which may necessitate canceling or restarting the treatment or transferring the patient to an alternate system.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the affected units.

The recalled product

Product: Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiology Equipment
Hazard: display-failure
treatment-interruption
Affected units: 14

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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