Agency classClass IIOur severity:High FDA (Devices)·Z-2313-2018·Announced 2018-07-04

Siemens Artis zee MP Recall for Display Failure After Power Save

Siemens is recalling Artis zee MP systems 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 risk-of-harm product where the display failure 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 the Artis zee MP, Material no. 10094139, used for angiography and whole body radiographic/fluoroscopic procedures. The recall is due to a defect 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 the United States, Puerto Rico, and numerous international locations.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the display issue and ensure patient safety during procedures.

The recalled product

Product: Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiographic Equipment
Hazard: display-failure
procedure-interruption
Affected units: 1

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)

157707

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 →

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