Siemens ARTIS zee and zeego X-ray Systems Recalled for Software Issue
Siemens is recalling 29 ARTIS zee and zeego x-ray systems due to a software issue affecting rotational 3D-acquisition programs with real-time subtraction.
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, and the source text describes a software restriction without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 29 ARTIS zee and zeego x-ray, angiographic systems. The affected units are equipped with Software Artis VC20x/VC21A, Patch 7, and a 3D and DSA license. The recall covers model numbers 10094137, 10094139, 10094141, and 10280959.
The recall is due to a potential issue with DSA rotational acquisition. Specifically, the restriction applies to any rotational 3D-acquisition program with real-time subtraction, such as 3D DSA. The source text notes the issue is related to the fill phase of the rotational acquisition.
The affected units were distributed nationwide and in Puerto Rico. Siemens issued a customer safety advisory notice and field safety corrective action to address this issue.
The recalled product
- Product
- ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray System
- Hazard
- Affected units
- 29
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 (4)
- Model numbers: 10094137
- 10094139
- 10094141
- 10280959
Distribution
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