Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0486-2015·Announced 2014-12-10

Siemens Artis zee Angiography System Software Recall

Siemens is recalling 1,131 Artis zee and zeego Angiography Systems due to a software issue that prevents deactivating the radiation block function after a network problem.

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 2/5 (Moderate).

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, but the source text describes a functional limitation (inability to deactivate a block function) without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor operational defects.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 1,131 units of the Artis zee and zeego Angiography Systems. The recall involves specific model numbers and serial numbers distributed worldwide, including the United States and numerous international locations.

The recall is due to a potential issue with the VC1x software. If a network problem occurs, the "Block Radiation" function may not be deactivated by pressing the key on the touch screen control. In this scenario, the system's image generation function is unavailable for patient examinations unless the system is manually switched off and back on.

Healthcare facilities using these systems should verify their equipment against the provided model and serial number lists. Siemens is addressing the issue to ensure the radiation block function can be properly managed during network interruptions.

The recalled product

Product: The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Angiography System
Hazard: software-defect
functional-limitation
Affected units: 1,131

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 (6)

model numbers: 10094135
10094137
10094139
10094141
10094142
10094143

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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