The Recall Desk
ModerateFDA (Devices)·Z-2309-2018·Announced 2018-07-04

Siemens Artis zee Biplane MN Recalled for Display Failure

Siemens is recalling two Artis zee biplane MN systems because the large display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional failure that may require procedure interruption or patient transfer, but no injuries or deaths are reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling two units of the Artis zee biplane MN, Material no. 10094143, 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 functionality remains active.

This issue does not occur during an ongoing procedure. If the defect manifests, 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 have been distributed worldwide, including in the United States, Puerto Rico, and numerous international locations.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and necessary corrective actions.

The recalled product

Product
Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
2

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)

  • 10094143 10094143

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 failure

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