Agency classClass IIOur severity:High FDA (Devices)·Z-2303-2018·Announced 2018-07-04

Siemens Artis Q Biplane Recalled for Display Failure After Power Save

Siemens is recalling five Artis Q biplanes because the display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.

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 high-risk medical device where a display failure could lead to procedure cancellation or patient transfer, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling five Artis Q biplane systems, Material no. 10848282, 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.

This 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.

Hospitals and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. No specific instructions for individual patients are provided in the source text, but patients should consult their healthcare providers if they have concerns about recent procedures involving these devices.

The recalled product

Product: Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: display-failure
procedure-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)

121004 121019 121016 121008 121023

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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