Agency classClass IIOur severity:High FDA (Devices)·Z-0516-2022·Announced 2022-02-02

Artis icono diagnostic imaging system software defects recalled nationwide

Siemens is recalling 72 units of Artis icono biplane diagnostic imaging systems nationwide due to four software issues that could disable x-ray capability, corrupt diagnostic images, or cause unexpected shutdowns during procedures.

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 medical device recall. While no injuries or illnesses have been reported, the software issues—including x-ray system failures, corrupted diagnostic images, and unexpected shutdowns—represent genuine risks to proper device operation and patient care during diagnostic procedures.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 72 units of the Artis icono biplane diagnostic imaging angiography system (Model 11327600) with software VE20C nationwide across U.S. medical facilities.

The recall addresses four potential software issues: (1) Updated calibration data may not be saved with measurements following scene adjustments, potentially affecting measurement accuracy; (2) The system may become unable to perform x-ray procedures and may require shutdown and restart during diagnostic interventions; (3) Images captured during roadmap procedures may become corrupted; and (4) The imaging system may shut down unexpectedly when equipped with an Uninterruptible Power Supply (UPS) option.

No injuries or illnesses have been reported in connection with these software issues. Affected medical facilities have been notified and should contact Siemens Medical Solutions USA, Inc. for instructions regarding software updates or other corrective measures.

The recalled product

Product: Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging System
Hazard: calibration-data-loss
x-ray-unavailability
image-corruption
system-shutdown
Affected units: 72

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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