The Recall Desk
HighFDA (Devices)·Z-2308-2018·Announced 2018-07-04

Siemens Artis zee Biplane Recalled for Display Failure After Power Save

Siemens is recalling 68 Artis zee biplane systems because the large display may remain black after exiting power save mode, potentially requiring treatment cancellation or patient transfer.

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 failure could lead to treatment cancellation or patient transfer, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 68 units of the Artis zee biplane (Material no. 10094141), a medical device used for angiography and whole-body radiographic and fluoroscopic procedures. The recall is due to a software issue where the Large Display may fail to show an image and remain black without displaying an error message after the system returns from power save mode.

This defect does not occur during an ongoing procedure. However, if the issue arises, the system cannot be operated normally. In such cases, it may be necessary to cancel or restart the treatment, or transfer the patient to an alternate or another 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. Patients and consumers should consult their healthcare providers if they have questions regarding their recent procedures.

The recalled product

Product
Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
68

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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