Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2344-2016·Announced 2016-08-17

Siemens Artis Angiography Systems Recalled for Image Reproduction Failure

Siemens Medical Solutions is recalling 51 Artis zee and Artis Q angiography systems due to a software error that may cause image loss after startup.

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. The hazard is a software error causing potential data loss (images) rather than direct physical injury, and no injuries or illnesses are reported, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 51 units of the Artis zee/zeego and Artis Q/Q.zen stand-alone angiography systems. These software-controlled systems are used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography. The recall covers specific model numbers and serial numbers distributed nationwide to 23 states.

The recall is due to an error in the 19 Live Display software. This error may cause image reproduction to fail in the examination room, creating a potential for the loss of images immediately after the system starts up. The source text does not report any injuries, illnesses, or deaths associated with this defect.

Healthcare facilities that have these specific systems should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the software issue. Consumers are not directly affected as these are professional medical devices.

The recalled product

Product: Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Angiography System
Hazard: software-error
data-loss
Affected units: 51

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 (20)

Serial Numbers: 121185
147996
121169
105032
109190
109191
109197
109198
125100
158225
161021
154847
124083
123050
109187
124102
121167
125021
121163
117125

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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