The Recall Desk
HighFDA (Devices)·Z-2310-2018·Announced 2018-07-04

Siemens Artis zee Ceiling Recalled for Display Malfunction

Siemens is recalling 73 Artis zee ceiling units 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 risk-of-harm product (medical device) where the malfunction could lead to procedure cancellation or patient transfer, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 73 Artis zee ceiling units (Material no. 10094137) used for angiography and whole body radiographic/fluoroscopic procedures. The recall is due to a software issue 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.

The defect does not occur during ongoing procedures. If the issue arises, 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 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 or replace the affected units.

The recalled product

Product
Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures.
Affected units
73

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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