Agency classClass IIOur severity:High FDA (Devices)·Z-0956-2023·Announced 2023-01-25

ARTIS medical imaging systems recalled for mechanical connection failure

Siemens ARTIS pheno and ARTIS icono imaging systems are recalled because the mechanical connection between the tabletop and table base may fail. The recall affects 550 units distributed worldwide.

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: This is an FDA Class II recall involving a structural mechanical defect in medical imaging equipment. Although no injuries or illnesses have been reported, the hazard presents a risk of harm if the tabletop detaches during use, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor imaging systems due to a potential mechanical failure. The mechanical connection between the tabletop and table base may be lost.

These systems have been distributed worldwide to the United States and 49 additional countries, affecting 550 units. The defect has been classified as FDA Class II.

The recalled systems can be identified by their product material numbers and UDI/DI codes: ARTIS pheno (Material #10849000, UDI: 4056869046877), ARTIS icono biplane (Material #11327600, UDI: 4056869063317), and ARTIS icono floor (Material #11327700, UDI: 4056869149325). Healthcare facilities can verify their equipment against these identifiers. Further information is available from Siemens Medical Solutions USA, Inc. and the FDA.

The recalled product

Product: ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device
Hazard: mechanical-failure
fall-injury
Affected units: 550

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 (7)

1) ARTIS pheno
Material #10849000
UDI/DI: 4056869046877 2) ARTIS icono biplane
Material #11327600
UDI/DI: 4056869063317 3) ARTIS icono floor
Material #11327700
UDI/DI: 4056869149325

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

Moderate
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High
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High
ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
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High
ARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10

Same hazard · mechanical failure