Agency classClass IIOur severity:High FDA (Devices)·Z-2304-2018·Announced 2018-07-04

Siemens Artis Q Ceiling Recalled for Display Failure After Power Save

Siemens Medical Solutions is recalling five Artis Q ceiling units because the display may fail to show an image after exiting power save mode, potentially requiring treatment cancellation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 failure could lead to treatment interruption 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 five units of the Artis Q ceiling, Material no. 10848281, used for angiography and whole body radiographic/fluoroscopic procedures. The recall is due to a software issue 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 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. The recall number is Z-2304-2018.

The recalled product

Product: Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiography Equipment
Hazard: display-failure
treatment-interruption
Affected units: 5

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)

109011 109009 109007 109020 109010

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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